Devices, systems, and methods for repairing soft tissue and attaching soft tissue to bone

ABSTRACT

Devices, systems and/or methods for repairing soft tissue adjacent a repair site. In one embodiment, a repair device is delivered with a delivery device system configured to move a cartridge with the repair device disposed therein toward an anvil with soft tissue positioned thereon. The delivery device linearly moves the cartridge toward the anvil with a worm drive positioned within a housing by rotating a thumb wheel disposed around the worm drive. Such linear movement is provided with a finger element extending from the worm drive that is configured to cooperate with an internal surface of the thumb wheel. With this arrangement, upon rotating the thumb wheel, the worm drive rotates with the finger element engaged with the internal surface of the thumb wheel to linearly move the cartridge toward the anvil.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 15/719,346, filed Sep. 28, 2017, which claims the benefit of U.S.Provisional Application No. 62/401,042, filed Sep. 28, 2016, thedisclosures of which are hereby incorporated by reference herein intheir entirety. Further, U.S. patent application Ser. No. 15/719,346also claims the benefit, and is a continuation-in-part of, U.S. patentapplication Ser. No. 14/885,959, filed Oct. 16, 2015, which claims thebenefit of U.S. Provisional Application No. 62/215,739, filed Sep. 9,2015, U.S. Provisional Application No. 62/129,742, filed Mar. 6, 2015,U.S. Provisional Application No. 62/094,032, filed Dec. 18, 2014, andU.S. Provisional Application No. 62/064,533, filed Oct. 16, 2014, thedisclosures of each are hereby incorporated by reference herein in theirentirety. Further, U.S. patent application Ser. No. 14/885,959 alsoclaims the benefit, and is a continuation-in-part of, U.S. patentapplication Ser. No. 14/645,924, filed Mar. 12, 2015, now U.S. Pat. No.9,629,632, which claims the benefit of U.S. Provisional PatentApplication No. 62/053,056, filed Sep. 19, 2014, U.S. Provisional PatentApplication No. 62/040,451, filed Aug. 22, 2014, U.S. Provisional PatentApplication No. 62/007,783, filed Jun. 4, 2014, and U.S. ProvisionalPatent Application No. 61/952,114, filed Mar. 12, 2014, the disclosuresof each are hereby incorporated by reference herein in their entirety.Further, the above-listed U.S. patent application Ser. No. 14/645,924claims the benefit, and is a continuation-in-part of, U.S. patentapplication Ser. No. 13/953,709, filed Jul. 29, 2013, now U.S. Pat. No.9,427,309, which claims the benefit of U.S. Provisional PatentApplication No. 61/804,570, filed Mar. 22, 2013, and U.S. ProvisionalPatent Application No. 61/677,239, filed Jul. 30, 2012, the disclosuresof each are hereby incorporated by reference herein in their entirety.

TECHNICAL FIELD

The present invention relates generally to soft tissue repair sites.More particularly, the present invention relates to devices, systems,and methods for repairing soft tissue and attaching soft tissue to bone.

BACKGROUND

Lacerated flexor tendon repair, as an example, is a procedure performedtens-of-thousands of times a year in the United States alone. For alltypes of tendons in the human anatomy, early post-operative mobilizationis beneficial to restoring maximal tendon function following injury andrepair. Adhesion formation is a common complication following tendonrepair, but can be reduced through motion rehabilitation programs assoon as possible following a surgery. By preventing adhesion formationand gliding resistance, tendon healing may be enhanced. However, thefailure rate of tendon repairs is close to 30 percent, primarily becauseof overloading at the repair site. Although an objective of tendonrepair is to provide adequate strength for passive and active motionduring rehabilitation, it is important to maintain a delicate balancebetween rehabilitative motion protocols and fatiguing the repair site.

Typical procedures for lacerated tendon repair use one or more suturesto mend the two ends of a tendon together using complex suture patterns.While this can provide a good initial repair, the strength and qualityof the repair may quickly degrade with subsequent loading andmobilization. Although postoperative therapy may be utilized to reduceadhesion, the resulting tension can induce gap formation or tendonrupture at the repair site, seriously impairing the outcome of therepair. Gapping at the repair site has many negative effects, such asreduced repair strength, tendon rupture, and an increased probabilityfor adhesion. Further, complex suture patterns are also used forfixating soft tissue, such as tendon and ligaments, to bone, resultingin similar negative effects to the patient and often result insubsequent procedures depending on the activity level of the patient.Furthermore, such complex suturing procedures are time consuming andtypically require specialized surgeons to perform such procedures.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to various devices,systems and methods for repairing soft tissue at a soft tissue repairsite. For example, in one embodiment, a delivery device system forfixating a repair device to soft tissue at a soft tissue repair site isprovided. The delivery device system includes an applicator assemblythat includes a housing, a worm drive, a thumb wheel, a cartridge, and afinger element. The housing and the cradle may be fixed to each other.The worm drive is positioned within the housing. The thumb wheel isdisposed around the worm drive such that the thumb wheel is configuredto be rotated to linearly move the worm drive with threads defined in atleast one of the worm drive and the thumb wheel. The cartridge iscoupled to a distal end of the worm drive, the cartridge beingconfigured to hold anchors of the repair device such that the cartridgeis configured to be linearly moved relative to a bed surface of thecradle. The finger element extends from the worm drive and is configuredto cooperate with an internal surface of the thumb wheel. With thisarrangement, upon rotating the thumb wheel, the worm drive rotates withthe finger element engaged with the internal surface of the thumb wheel.

In one embodiment, the internal surface of the thumb wheel definesmultiple slots therein, the finger element sized to linearly translatealong one slot of the slots as the worm drive rotates. In a furtherembodiment, upon the cartridge being linearly moved against the softtissue positioned in the cradle, the finger element is configured toslip-out of the one slot to prevent further linear movement of thecartridge toward the bed surface of the cradle. In another embodiment,the finger element includes a circular member. In another embodiment,the finger element includes a ring structure. In a further embodiment,the finger element is fixed to the worm drive. In still a furtherembodiment, the finger element is positioned off-center relative to anaxis of the worm drive.

In another embodiment, the finger element cooperates with the internalsurface of the thumb wheel to limit a force applied to the soft tissueupon the cartridge being linearly moved against the soft tissue. In afurther embodiment, the force applied to the soft tissue by a distal endof the cartridge is a function of a bendability of the finger element.In another embodiment, the finger element cooperates with the internalsurface of the thumb wheel by linearly translating along a length of theinternal surface of the thumb wheel and by slipping over a ratchet-likesurface of the internal surface of the thumb wheel.

In another embodiment, the delivery device system further includes afiring mechanism operatively coupled to a proximal end of the wormdrive. In a further embodiment, the firing mechanism includes a handleassociated with a trigger, the handle and trigger sized and configuredto manually deploy the repair device into the soft tissue. In anotherembodiment, the delivery devices system further includes a strokeregulator positioned between the firing mechanism and the worm drive. Inan further embodiment, the stroke regulator includes an elastomermaterial.

In accordance with another embodiment of the present invention, adelivery device system for fixating a repair device to soft tissue at asoft tissue repair site is provided. The delivery device system includesa deployment mechanism, a housing, an anvil, a worm drive, a thumb wheeland a finger element. The deployment mechanism includes a handleassociated with a trigger, the handle and trigger sized and configuredto manually deploy the repair device into soft tissue with a push rodmoveable along an axis. The push rod is linearly moveable by thedeployment mechanism and extends distally from the deployment mechanism.The housing extends longitudinally along the push rod. The anvil andcartridge are configured to be coupled to the housing, the cartridgebeing at least partially holding the repair device. The worm drive ispositioned within the housing. The thumb wheel is disposed around theworm drive, the thumb wheel being configured to be rotated to linearlymove the worm drive with threads defined in at least one of the wormdrive and the thumb wheel such that the worm drive is configured tolinearly move the cartridge relative to a bed surface of the anvil. Thefinger element extends from the worm drive and is configured tocooperate with an internal surface of the thumb wheel. With thisarrangement, upon rotating the thumb wheel, the worm drive rotates withthe finger element engaged with the internal surface of the thumb wheel.

In one embodiment, the internal surface of the thumb wheel definesmultiple slots therein, the finger element sized to linearly translatealong one slot of the slots as the worm drive rotates. In a furtherembodiment, upon the cartridge being linearly moved against the softtissue positioned in the anvil, the finger element is configured toslip-out of the one slot to prevent further linear movement of thecartridge toward the bed surface of the anvil. In another embodiment,the finger element includes a circular member. In still anotherembodiment, the finger element includes a ring structure.

In another embodiment, the delivery device system further includes astroke regulator positioned between the deployment mechanism and theworm drive. In a further embodiment, the stroke regulator includes anelastomer material.

In accordance with another embodiment of the present invention, adelivery device system configured to move a cartridge with a repairdevice disposed therein toward an anvil with soft tissue positionedthereon for fixating the repair device to the soft tissue at a softtissue repair site is provided. The delivery device system includes ahousing, a worm drive, a thumb wheel and a finger element. The wormdrive is at least partially positioned within the housing. The thumbwheel is disposed around the worm drive, the thumb wheel configured tobe rotated to linearly move the worm drive with threads defined in atleast one of the worm drive and the thumb wheel such that the worm driveis configured to linearly move the cartridge relative to a bed surfaceof the anvil. The finger element extends from the worm drive and isconfigured to cooperate with an internal surface of the thumb wheel.With this arrangement, upon rotating the thumb wheel, the worm driverotates with the finger element engaged with the internal surface of thethumb wheel.

In one embodiment, the finger element includes or exhibits a circularmember. In another embodiment, the finger element cooperates with theinternal surface of the thumb wheel by linearly translating along alength of the internal surface of the thumb wheel such that the fingerelement limits a force of the cartridge being pushed against the softtissue by the finger element slipping out of a slot defined in theinternal surface of the thumb wheel.

In accordance with another embodiment of the present invention, adelivery system for fixating a repair device to soft tissue at a softtissue repair site is provided. The delivery system includes a firingmechanism, an actuator member, and a device delivery portion. Theactuator member is operatively coupled to the firing mechanism. Theactuator member includes an actuation portion positioned within a tubestructure, the tube structure having a finger holder positioned at aproximal portion of the tube structure and the actuation portion havinga thumb holder positioned at a proximal portion of the actuationportion. The device delivery portion including a cartridge and a cradle,the cartridge slidable relative to the cradle. The cradle is configuredto be fixed relative to the tube structure and the cartridge isconfigured to be coupled to the actuation portion of the actuationmember. The device delivery portion is configured to hold the repairdevice. With this arrangement, linear movement of the actuation portiontranslates linear movement of the cartridge relative to the cradle.

In one embodiment, the tube structure includes indicia to determine athickness of the soft tissue to be fixated. In another embodiment, thefinger holder and the thumb holder facilitate manual actuation of theactuation portion. In another embodiment, the firing mechanism includesa handle associated with a lever for manually activating the firingmechanism. In another embodiment, the firing mechanism is activated withat least one of a manual lever, a hydraulic mechanism, and a pneumaticmechanism.

In accordance with another embodiment of the present invention, a repairdevice system for fixating soft tissue at a soft tissue repair site isprovided. The repair device system includes a bed surface, a platemember, and an anchor. The bed surface of a delivery device definesanvil buckets therein. The plate member is positioned over the bedsurface and configured to be positioned along an outer surface of thesoft tissue. The anchor includes a base with at least four legsextending from the base, the base defining a longitudinal base axis withat least two legs extending from opposing sides of the base. The atleast four legs configured to be forced against the anvil buckets tomove the at least four legs to a curled configuration such that the atleast four legs wrap around separate portions of the periphery of theplate member.

In one embodiment, adjacent legs of the at least two legs on a singleside of the base of the anchor extend from the base at differentdistances relative to the longitudinal base axis. In another embodiment,adjacent legs extending from the base on a single side of the anchorextend from the base at different distances relative to the longitudinalbase axis.

In another embodiment, a leg of the at least four legs includes one ormore tapers along the length thereof sized and configured to facilitatethe legs to move to the curled configuration. In another embodiment, aleg of the at least four legs includes a taper extending with an anglebetween about 1 degree and 10 degrees. In another embodiment, the anchorincludes six legs each configured to be forced against the anvil bucketsto move the six legs to a curled configuration such that the six legswrap around separate portions of the plate member.

In accordance with another embodiment of the present invention, a methodfor repairing soft tissue is provided. The method includes providing adelivery device with a cartridge and an anvil, the cartridge holding oneor more anchors, each anchor having a base portion and at least fourlegs extending from the base portion, the anvil defining a bed surfacesized to receive one or more plate members; positioning soft tissue overthe one or more plate members positioned on the bed surface such thatthe soft tissue is positioned between the one or more plate members andthe one or more anchors; and forcing the one or more anchors from thecartridge with the delivery device so that the at least four legs extendthrough the soft tissue and are compressed against anvil buckets definedin the bed surface to force the at least four legs of each anchor tocurl around separate portions of one of the one or more plate members sothat the base portion of the one or more anchors is positioned over anopposite side of the soft tissue relative to the one or plate members.

In one embodiment, the step of forcing includes forcing the anchorstoward the anvil in a direction parallel to a delivery device axis suchthat the bed surface of the anvil extends longitudinally to define ananvil axis, the anvil axis being substantially perpendicular to thedelivery device axis. In another embodiment, the step of positioningincludes positioning the soft tissue over a first plate member of theone or more plate members and positioning soft tissue over a secondplate member of the one or more plate members such that the first andsecond plate members are longitudinally aligned within the bed surfaceof the anvil. In still another embodiment, the step of forcing includesforcing a first anchor and a second anchor of the one or more anchors sothat the at least four legs of each of the first and second anchorsextend through the soft tissue and curl around separate portions of therespective first and second plate members.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing and other advantages of the invention will become apparentupon reading the following detailed description and upon reference tothe drawings in which:

FIG. 1 is a side view of one embodiment of a soft tissue repair devicewith a portion of the delivery device in outline form, depicting thesoft tissue repair device with one or more rigid members positionedopposite a flexible member and anchors in a pre-deployed state,according to the present invention;

FIG. 2 is a perspective view of the flexible member of the soft tissuerepair device of FIG. 1, according to another embodiment of the presentinvention;

FIG. 3 is a perspective view of the one or more rigid members of FIG. 1,depicting the one or more rigid members in a pre-formed flat state,according to another embodiment of the present invention;

FIG. 4 is a front view of one of the anchors for the soft tissue repairdevice of FIG. 1, according to another embodiment of the presentinvention;

FIG. 4A is a perspective view of the anchor of FIG. 4, according to thepresent invention;

FIG. 5 is a perspective view of another embodiment of one of the anchorsfor the soft tissue repair device of FIG. 1, according to the presentinvention;

FIG. 6 is a side view of the soft tissue repair device in a deployedstate, according to another embodiment of the present invention;

FIG. 6A is a cross-sectional view of the soft tissue repair device takenalong section line A-A in FIG. 6, according to another embodiment of thepresent invention;

FIG. 6B is a cross-sectional view of the soft tissue repair device takenalong section line B-B in FIG. 6, according to another embodiment of thepresent invention;

FIG. 7 is a top view of a cradle portion of the delivery device,depicting canted anvil buckets in a bed surface of the cradle portion,according to another embodiment of the present invention;

FIG. 8 is a perspective view of an upper rigid substrate, the upperrigid substrate being a component of a soft tissue repair device,according to another embodiment of the present invention;

FIG. 9 is a perspective view of a rigid member, the rigid member being acomponent of a soft tissue repair device, according to anotherembodiment of the present invention;

FIG. 10 is a side view of a repair device, depicting the repair devicefixating soft tissue to bone, according to another embodiment of thepresent invention;

FIG. 11 is an exploded view of another embodiment of a repair devicesystem, depicting upper and lower substrates, anchors, a bone anchor,and an anvil, according to the present invention;

FIG. 11A is a top cross-sectional view taken above the lower substrate,depicting an anchor relative to anvil beds, according to anotherembodiment of the present invention;

FIG. 11B is a side view of the repair device system, depicting theanchor fixating tissue with the upper and lower substrates, according toanother embodiment of the present invention;

FIG. 12 is a side view of the repair device system, depicting the repairdevice system fixating soft tissue to bone, according to anotherembodiment of the present invention;

FIG. 13 is a simplified perspective view of another embodiment of aflexible member integrated with multiple anchors, the flexible memberbeing a component of a repair device, according to the presentinvention;

FIG. 14 is a simplified perspective view of a flexible wrap member, theflexible wrap member being a component of a repair device and sized tosurround soft tissue and a soft tissue repair site, according to anotherembodiment of the present invention;

FIG. 14A is a cross-sectional view of the flexible wrap member,according to another embodiment of the present invention;

FIG. 15 is a side view of a repair device, depicting the repair devicewith the flexible wrap surrounding soft tissue and positioned betweenanchors and the rigid member, according to another embodiment of thepresent invention;

FIG. 16 is a simplified view of a capture device adjacent a soft tissuerepair site of an achilles tendon, according to another embodiment ofthe present invention;

FIG. 17 is a side view of a repair device, depicting the repair devicefor repairing the Achilles tendon, according to another embodiment ofthe present invention;

FIG. 18 is a side view of another embodiment of a repair device,depicting the repair device having a first part and a second partcoupled together with a filament synch, according to the presentinvention;

FIG. 18A is a cross-sectional view of the repair device taken alongsection line A-A of FIG. 18, according to another embodiment of thepresent invention;

FIG. 19 is a side view of the repair device similar to FIG. 18,depicting the first and second parts moved adjacent each other with thefilament synch, according to another embodiment of the presentinvention;

FIG. 19A is a simplified side view of a locking mechanism of the repairdevice of FIG. 18, according to another embodiment of the presentinvention;

FIG. 20 is a side view of a tissue growth member positioned adjacent asoft tissue repair site of soft tissue, the tissue growth member being acomponent employed with a repair device, according to another embodimentof the present invention;

FIG. 21 is a side view of the tissue growth member positioned within thesoft tissue along and adjacent the soft tissue repair site, according toanother embodiment of the present invention;

FIG. 21A is a cross-sectional view taken along section A-A of FIG. 21,depicting the tissue growth member positioned adjacent and along fibersof the soft tissue, according to another embodiment of the presentinvention;

FIG. 22 is a side view of another embodiment of a repair device,depicting a portion of a delivery system in outline form, according tothe present invention;

FIG. 23 is a perspective view of the repair device of FIG. 22, depictingthe repair device having first and second anchors with opposing firstand second plate members, according to another embodiment of the presentinvention;

FIG. 24 is a top view of one of the anchors, depicting the anchor in apre-formed state, according to another embodiment of the presentinvention;

FIG. 25 is a top view of one of the plate members, depicting the platemember in a pre-formed state, according to another embodiment of thepresent invention;

FIG. 26 is a perspective view of the repair device, depicting thealignment of legs of the first and second anchors corresponding withnotches and openings of the first and second plate members;

FIG. 27 is a top view of a bed surface of a cradle portion, according toanother embodiment of the present invention;

FIG. 27A is a partial top view of the bed surface of the cradle portionwith the first plate member positioned over the bed surface of thecradle portion, according to another embodiment of the presentinvention;

FIG. 28 is a perspective view of an elongated handle assembly, depictinga cartridge dis-engaged with the elongated handle assembly, according toanother embodiment of the present invention;

FIG. 29 is an enlarged perspective view of the cartridge, according toanother embodiment of the present invention;

FIG. 30 is rear view of the cartridge, according to another embodimentof the present invention;

FIG. 31 is a front view of the cartridge, according to anotherembodiment of the present invention;

FIG. 32 is a perspective view of the elongated handle assembly with thecartridge engaged with the elongated handle assembly, according toanother embodiment of the present invention;

FIG. 32A is a cross-sectional side view of the elongated handle assemblytaken along section line A-A of FIG. 32, according to another embodimentof the present invention;

FIG. 32B is a cross-sectional side view of the elongated handle assemblytaken along section line B-B of FIG. 32, according to another embodimentof the present invention;

FIG. 33 is a perspective view of the elongated handle assembly with atrigger handle of the delivery device, according to another embodimentof the present invention;

FIG. 34 is a perspective view of a pusher member, according to anotherembodiment of the present invention;

FIG. 35 is a perspective view of the first and second plate memberspositioned within a cradle portion, according to another embodiment ofthe present invention;

FIG. 36 is a perspective view of the repair device and cradle portion,depicting the first and second anchors in a pre-deployed state aspositioned within the cartridge (not shown) and positioned above thefirst and second plate members in the cradle portion, according toanother embodiment of the present invention;

FIG. 37 is a perspective of the delivery device in a position foractuating the trigger handle, according to another embodiment of thepresent invention;

FIG. 38 is a top view of the repair device engaged with soft tissue,according to another embodiment of the present invention;

FIG. 38A is a cross-sectional view of repair device engaged with softtissue taken along section line A-A of FIG. 38, according to anotherembodiment of the present invention;

FIG. 39 is a side view of the repair device engaged with soft tissue,according to another embodiment of the present invention;

FIG. 40 is a perspective view of another embodiment of first and secondanchors of a repair device, according to the present invention;

FIG. 41 is a perspective view of another embodiment of first and secondplate members, according to the present invention;

FIG. 42 is a perspective view of another embodiment of a cradle portion,according to the present invention;

FIG. 43 is a top view of the cradle portion of FIG. 42, according toanother embodiment of the present invention;

FIG. 44 is a top view of the first and second plate members positionedin the cradle portion, according to another embodiment of the presentinvention;

FIG. 45 is a perspective view of a repair device, depicting the firstand second anchors positioned above the respective first and secondplate members, according to another embodiment of the present invention;

FIG. 46 is a perspective view of another embodiment of a cradle portion,according to the present invention;

FIG. 47 is a perspective view of the cradle portion of FIG. 46,depicting first and second plate members positioned over the cradleportion, according to another embodiment of the present invention;

FIG. 48 is an enlarged side view of some of the legs of the firstanchors, according to another embodiment of the present invention;

FIG. 49 is an end view of one of the anchors, according to anotherembodiment of the present invention;

FIG. 50 is a perspective view of a delivery device, according to anotherembodiment of the present invention;

FIG. 51 is an exploded view of various components of the deliverydevice, according to another embodiment of the present invention;

FIG. 51A is an enlarged exploded view of various components of a distalportion of the delivery device system, depicting various features of thecomponents, according to another embodiment of the present invention;

FIG. 52 is a cross-sectional view of the delivery device taken alongsection line A-A of FIG. 50, according to another embodiment of thepresent invention;

FIG. 53A is a partial top view of the delivery device, depicting severedsoft tissue positioned over the cradle portion of the delivery device,according to another embodiment of the present invention;

FIG. 53B is a partial top view of the delivery device, depicting acartridge being moved toward the cradle portion of the delivery device,according to another embodiment of the present invention;

FIG. 53C is a partial top view of the delivery device, depicting thecartridge moved adjacent the cradle portion to a position prior tofixating the severed soft tissue, according to another embodiment of thepresent invention;

FIG. 54A is a top view of the repair device fixated to the severed softtissue, according to another embodiment of the present invention;

FIG. 54B is a bottom view of the repair device fixated to the severedsoft tissue, according to another embodiment of the present invention;

FIG. 55A is a top view of one or more repair devices, depicting firstanchors of the one or more repair devices fixating soft tissue to bonewith a bone anchor, according to another embodiment of the presentinvention;

FIG. 55B is a bottom view of the one or more repair devices, depictingfirst plate members coupled to arms of the first anchors of the one ormore repair devices fixating soft tissue to bone with the bone anchor,according to another embodiment of the present invention;

FIG. 56 is a perspective view of a repair device, depicting the repairdevice in a deployed state, according to another embodiment of thepresent invention;

FIG. 57 is a top view of the repair device of FIG. 56, according toanother embodiment of the present invention;

FIG. 58 is a side view of the repair device of FIG. 56 deployed withinsoft tissue, according to another embodiment of the present invention;

FIG. 59 is a cross-sectional view of an applicator assembly, depicting aslip clutch element integrated with the applicator assembly, accordingto another embodiment of the present invention;

FIG. 59A is an enlarged view of the slip clutch element, according toanother embodiment of the present invention;

FIG. 59B is a cross-sectional view of the applicator assembly takenlaterally relative to the longitudinal length of the applicator assemblyalong the slip clutch element, according to another embodiment of thepresent invention; and

FIG. 60 is another embodiment of a delivery device for delivering arepair device, according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Various embodiments are disclosed herein of a soft tissue repair device.Such repair device may be sized and configured to approximate and fuse,for example, a lacerated tendon. The various embodiments may providestructure that maintains two ends of a lacerated tendon in an abuttingrelationship, without gapping, while allowing the tendon adjacent thetendon ends and along the length of the repair device to providecontrolled elongation of the tendon. In this manner, the repair deviceof the present invention may provide the proper healing required forfusing the tendon ends while still providing movement of the tendon tominimize atrophy and potential adhesions.

With reference to FIG. 1, one embodiment of a repair device 30, shown ina pre-deployed state, is provided. The repair device 30 may include aflexible member 32 and one or more rigid members 24 that may be coupledtogether with anchors 36. The flexible member 32 may be positionedrelative to separate and discrete anchors 36 in a pre-deployed statewithin a cartridge 24 (generally shown in outline form) integrated witha delivery device 22. The delivery device and cartridge arrangement (andother delivery device and system components) may be similar to thatdescribed in commonly owned U.S. Non-Provisional patent application Ser.No. 14/645,924, the disclosure of which is incorporated by referenceherein in its entirety, the disclosure describing in detail a deliverydevice that may be employed with the repair device of this embodiment.As set forth, in this embodiment, the repair device 30 may include oneor more rigid members 34 positioned oppositely from the flexible member32 and positioned within a cradle portion 26 (shown in outline) of thedelivery device 22. For example, for tendons in the hand, such as inzone two of the hand anatomy, the flexible member 32 may be positionedover a palmar side 15 of the tendon 5 and the one or more rigid members34 may be positioned over (or under) a dorsal side 17 of the tendon 5.In this manner, while the repair device 30 is in a pre-deployed state,the flexible member 32 and the one or more rigid members 34 may bepositioned in a generally parallel arrangement with the anchors 36suspended within the cartridge 24 positioned perpendicular relative tothe flexible member 32.

With reference to FIG. 2, further to the various embodiments describedin the above-noted U.S. Provisional Patent Applications for the flexiblemember 32 or ribbon, the flexible member 32 may be a filamentary member.Further, in one embodiment, the flexible member 32 may be sized andconfigured with one or more filaments 38 so as to include multiple pores40. Although simplistically depicted, the filaments 38 may extend in amanner so as to be inter-woven, braided, and/or knitted, or the like todefine the pores 40 between adjacently extending filaments 38. The pores40 may include a pore size in the range of about 50-250 microns. Inanother embodiment, the flexible member 32 may be a monolithic structuredefining a multi-cellular structure. In one embodiment, the monolithicstructure may define pores 40 with the pore size in the range of about50-250 microns. In another embodiment, the flexible member 32 may be ahealing ingrowth substrate. For example, the pores 40 of the flexiblemember 32 may be sized and configured to induce tissue ingrowththerethrough such that, upon the occurrence of a gap or gap wideningbetween the severed tendon 5 (FIG. 1), the flexible member 32 and itspores 40 facilitate tissue ingrowth across the gap and through theflexible member 32 so as to bridge the gap and assist in filling apotential gap.

With respect to FIGS. 1 and 2, the flexible member 32 may be an elongatemember that may include a depth 42, a width 44, and a length 46. Thelength 46 of the flexible member 32 corresponds with the longitudinaldimension of the elongate member. The width 44 is smaller than thelength 46 and extends perpendicular to the length dimension and in acommon plane as the length dimension. The depth 42 is a thickness of theflexible member 32 and extends perpendicular to the dimensions of thelength 46 and width 44.

With respect to FIGS. 1 and 3, the one or more rigid members 34 will nowbe described. As set forth, the one or more rigid members 34 may bepositioned within a bed surface 28 of the cradle portion 26 (see FIG. 7)and be positioned parallel to the flexible member 32. The one or morerigid members 34 may be a single rigid member or multiple rigid members,such as two, three, or four rigid members or more. As depicted in thisexample, the one or more rigid members 34 may include two rigid members,such as a first rigid member 48 and a second rigid member 50. The firstand second rigid members 48, 50 may be coupled with a coupling structure52. The coupling structure 52 may be in the form of one or more filamentstructures or the like that are flexible so as to facilitate the firstand second rigid members 48, 50 to be moveable to different orientationsrelative to each other, upon the repair device 30 being secured to asevered tendon 5 or the like, but also substantially resist separationof the rigid members such that the coupling structure 52 resistselongation. In the event three rigid members 34 or more are employed,such rigid members may be shortened (or maintain a similar length) andinterconnected with multiple flexible coupling structures.

The first and second rigid members 48, 50 each may be generally flatstructures and elongated. For example, the first and second rigidmembers 48, 50 may be formed from a flat sheet of material via lasercutting or the like, as depicted in FIG. 3. As such, each of the firstand second rigid members 48, 50 may include and define an inner surface54 and outer surface 56, the inner and outer surfaces 54, 56 definedwith a periphery 58 having a depth 60 or thickness. Further, the firstand second rigid members 48, 50 may be positioned and oriented toinclude an outer end 62 and an inner end 64, the inner ends 64positioned adjacent each other and coupled with the coupling structure52. Furthermore, each of the first and second rigid members 48, 50 maydefine multiple openings 66 defined therein such that the first andsecond rigid members 48, 50 may be a multi-cellular structure.

In one embodiment, the first and second rigid members 48, 50 may includemultiple tines. Such multiple tines may be initially cut in a commonplane, as depicted in FIG. 3, and bent and formed to an uprightposition, as depicted in FIG. 1. The multiple tines may includeperipheral tines 68 and central tines 70 such that each of the multipletines may be formed to extend from the inner surface 54. The peripheraltines 68 may extend from opposing sides 74 and outer ends 62 of thefirst and second rigid members 48, 50. Further, the peripheral tines 68may extend substantially perpendicular relative to the inner surface 54and/or the peripheral tines 68 may extend in a canted manner toward therespective inner ends 64 of the first and second rigid members 48, 50.The central tines 70 may extend from at least some of the openings 66defined in each of the first and second rigid members 48, 50 and,further, the central tines 70 may extend perpendicularly and/or cantedrelative to the inner surface 54 of the first and second rigid members48, 50. Such peripheral and central tines 68, 70 may be sized andconfigured to engage and extend into soft tissue.

In another embodiment, each of the first and second rigid members 48, 50may include opposing notches 72 defined in the periphery 58 and alongthe opposing sides 74 of the first and second rigid members 48, 50. Eachof the opposing notches 72 may be defined adjacent to and on theopposite sides 74 of one of the openings 66 defined in the first andsecond rigid members 48, 50. In other words, each of the opposingnotches 72 includes one of the openings 66 therebetween. With thisarrangement, each of the opposing notches 72 and its correspondingopening 66 may be sized and configured to receive first and second legs78, 80 (see FIG. 6B) of the anchors 36 for securing the flexible member32 and rigid members 34 to the severed tendon 5, discussed in furtherdetail herein. Further, the first and second rigid members 48, 50 may beformed from a metallic material, such as stainless steel, titanium, orNitinol, or any other suitable material or combinations of materials.

Now with reference to FIGS. 1 and 4, a detailed view of one of theanchors 36 of the repair device 30 is provided. The anchors 36 mayinclude a generally u-shaped configuration with an upper portion 76having a first leg 78 and a second leg 80 extending from opposite endsof the upper portion 76. The upper portion 76 may also include a tine 82or center tine extending from the upper portion 76 such that the tine 82extends parallel with and between the first and second legs 78, 80 in acommon direction of the legs. Further, the upper portion 76 may define aspacing 84 between the first and second legs 78, 80. Such spacing 84between the first and second legs 78, 80 may be sized and configured toposition the flexible member 32 within the spacing 84 with the tine 82configured to extend through the flexible member 32 (shown in outline),such that the width 44 (FIG. 52) of the flexible member 32 may be sizedsmaller or about the same as the spacing 84.

With respect to FIGS. 4 and 4A, in one embodiment, each of the first andsecond legs 78, 80 may include portions that taper along their lengthtoward free ends 86 of the first and second legs 78, 80. In other words,the first and second legs 78, 80 may include varying widths along theirlengths. In another embodiment, the first leg 78 and the second leg 80may each include a first width 88 that extends from the upper portion 76along a first length 90, then tapers with a first taper 92 to extend toa second width 94 that extends along a second length 96, then againtapers with a second taper 98 to the free ends 86 of the first andsecond legs 78, 80. The second width 94 may be smaller than the firstwidth 88. Further, the second length 96 of each of the first and secondlegs 78, 80 may be greater than the first length 90. In anotherembodiment, the second length 96 of each of the first and second legs78, 80 may slightly taper toward distal ends 100 of the second length96. In another embodiment, the first and second legs 78, 80 extend fromthe upper portion 76 such that the spacing 84 of the first and secondlegs 78, 80 increases from the upper portion 76 to the distal end 100 ofthe second length 96 of the first and second legs 78, 80 and, along thesecond taper 98, the spacing 84 may be substantially constant such thatan outer surface 102 of the first and second legs 78, 80 along thesecond taper 98 extends inward to form the second taper 98. Such tapersalong the length of the first and second legs 78, 80 may be sized andconfigured to facilitate the legs to wrap and curl in a controlledmanner, upon being deployed and secured to the above-described one ormore rigid members 34, as depicted in FIG. 6B.

With reference to FIG. 5, another embodiment of an anchor 104 that maybe employed with the repair device 30 of FIG. 1 is provided. In thisembodiment, the anchor 104 is substantially the same as the anchor inFIG. 4, except in this embodiment, the anchor 104 may include two tines108 or two center tines, each of the two tines extending from an upperportion 106 of the anchor 104. The two tines 108 may extendsubstantially along with and parallel with legs 110 of the anchor 104and may be sized and configured to extend through the flexible member 34and into the soft tissue to which the anchor 104 is secured, similar tothat depicted in FIG. 6B.

Now with reference to FIGS. 1 and 6, as depicted, the repair device 30may be deployed for fixating and fusing together, for example, a severedtendon 5. As in previous embodiments, the severed tendon 5 may be placedover the cradle portion 26 of the delivery device 22. Further, as setforth, this embodiment includes the first and second rigid members 48,50, which are each positioned over the cradle portion 26 with theperipheral and central tines 68, 70 extending upward such that thesevered tendon 5 may be placed over the rigid members 34 with thesevered portion positioned over and between the inner ends 64 of thefirst and second rigid members 48, 50. The peripheral tines 68 and thecentral tines 70 may each be sized and configured to pierce theunderside surface or dorsal side 17 of the severed tendon 5.

With respect to FIGS. 1, 6 and 6B, the physician may trigger or actuatethe delivery device 22, which forces the first and second legs 78, 80 ofthe anchors 36 to extend through the flexible member 32 and anchor tothe severed tendon 5 with the upper portion 76 of the anchors 36sandwiching the flexible member 32 against the upper side or palmar side15 of the severed tendon 5. Further, the first and second legs 78, 80 ofeach of the anchors 36 are sized and configured to wrap around the firstand second rigid members 48, 50 so that the tendon 5 is positionedbetween the rigid members 34 and the flexible member 32.

With respect to FIGS. 6, 6A, 6B and 7, additional description of theanchors 36 coupling to both the flexible member 32 and the first andsecond rigid members 48, 50 are provided. Initially, upon triggering thedelivery device 22 (FIG. 1), the first and second legs 78, 80 of each ofthe anchors 36 may be forced to extend through the tendon 5 and thencontinue to extend through the opposing notches 72 of the first andsecond rigid members 48, 50. Once through the opposing notches 72, thefirst and second legs 78, 80 may then be forced against canted anvilbuckets 112 defined in a bed surface 28 of the cradle portion 26 (asshown in FIG. 7). The canted anvil buckets 112 may include a bucketsurface 114 with and defining a downward slope 116 extending to a bottom118 and then extending along an upward slope 120. The orientation of thecanted anvil buckets 112, an upstanding wall 115 (or functional wall),as well as the above-indicated slopes of the bucket surface 114, forcethe first and second legs 78, 80 of the anchors 36 to bend toward eachother and follow the canted anvil bucket 112 orientation so that thelegs curl past each other and loop through the opening 66 between thecorresponding opposing notches 72 in an over lapping manner, as depictedin FIG. 6B. The upstanding wall 115 of the anvil buckets 112 provides afunctional wall to guide and direct the respective legs to precise overlapping orientations. In this manner, the first and second legs 78, 80of each of the anchors 36 wrap around one of the first and second rigidmembers 48, 50 to secure the rigid members 34 and the flexible member 32to the severed tendon 5. Further, the first and second rigid members 48,50 stabilize the anchors 36 so that the upper portion 76 of the anchors36 synchs against the flexible member 32 so as to provide a quiltingeffect relative to the flexible member 32.

With respect to FIG. 8, another embodiment of a component of a repairdevice is provided. In this embodiment, rather than employing theabove-described flexible member, as set forth in previous embodimentsherein, the repair device may include an upper plate member 122. Assuch, the repair device of this embodiment may include similarcomponents set forth in the previous embodiment described relative toFIG. 1, but includes the upper plate member 122, rather than theflexible member. The upper plate member 122 may be a single elongatedmember that may be generally flat, as depicted in its cut form fromsheet material. The upper plate member 122 may be a rigid structure andmay include multiple openings 124 defined therein. The openings 124 maybe sized and configured to receive, for example, the tine 82 (FIG. 4) ofthe anchors 36. Further, the upper plate member 122 may include upperperipheral tines 126 that may be formed to a bent position (not shown)to extend generally perpendicular and/or canted relative to an innersurface 858 of the upper plate member 122. Such upper peripheral tines126 may be sized and configured to be forced into the soft tissue uponanchors 36 (upper portion 76 in FIG. 4) being forced against an outersurface 130 of the upper plate member 122. Further, the cantedorientation of the upper peripheral tines 126 may be canted toward acenter portion 132 of the upper plate member 122 so as to assist inmaintaining the severed tendon together.

With respect to FIG. 9, another embodiment of a component of a repairdevice is provided. In this embodiment, rather than first and secondrigid members, as described in previous embodiments, the repair deviceincludes an elongated single rigid member 134. This embodiment mayinclude similar features and structural characteristics as thebefore-described first and second rigid members 48, 50 (FIG. 3) tofacilitate the anchors 36 (FIG. 4) to wrap around opposing notches 136and curl through openings 138 defined between the opposing notches 136.In one embodiment, the single rigid member 134 may be more suitablyemployed for soft tissue in other anatomical areas than zone two in thehand anatomy. For example, the upper plate member 122 and single rigidmember 134, depicted in FIGS. 8 and 9, may be better suited for tendonsat the ankle, the knee, and shoulder, or any other tendons or softtissue in the body where the location of the severed tendon does notrequire the tendon to move over a radius.

In another embodiment, with respect to FIG. 10, a repair device 140similar to the repair device described in previous embodiments may beutilized to fixate a tendon 5 (or any soft tissue) to bone 19. Forexample, the repair device 140 may include a lower rigid member 142,such as the first rigid member 48 of FIG. 3, and an upper substrate 144with anchors 36 sized and configured to sandwich a tendon 5 between theupper substrate 144 and the lower rigid member 142. In one embodiment,the upper substrate 144 may be similar to the upper plate member 122 ofFIG. 8, but sized to correspond with the lower rigid member 142. Inanother embodiment, the upper substrate 144 may be the flexible member132, similar to previous embodiments described herein, sized andconfigured to correspond with the lower rigid member 142. The anchors 36may be positioned and attached to the tendon 5 so as to wrap and curlthrough openings defined in the lower rigid member 142, similar to thatdepicted in FIG. 6B.

The repair device 140 may also include a filament 146 sized andconfigured to couple to a bone anchor 148. The filament 146 may includea coupling portion 150 and an attachment portion 152. Further, thefilament 146 may be flexible and sized and configured to adapt forattachment to most any suitable bone anchor 148. The coupling portion150 of the filament 146 may couple to an opening 154 defined in theupper substrate 144 and the attachment portion 152 may include a loopthat may be synched or attached to the bone anchor 148. The filament 146may be in the form of a wire or suture and may be a metallic material ora polymeric material or any other suitable material known in the art.Further, as depicted, the bone anchor 148 may include a bone screw shaft156 or the like and may include a bone screw insert 158. The bone screwinsert 158 may be inserted and positioned within a pre-formed hole 21 inthe bone 19 and may include tines 160 to assist in preventing migrationfrom the bone 19. In another embodiment, the bone screw insert 158 maybe inserted within the hole 21 with adhesive to secure the bone screwinsert 888 within the bone 19. The bone screw insert 158 may alsoinclude threads on an inner surface thereof that correspond with threadsof the bone screw shaft 156. The bone screw shaft 156 may also include ascrew head 162 that may act to maintain the attachment portion 152 ofthe filament 146 as well as facilitate the physician to insert andremove the bone screw shaft 156, as indicated by arrow 164. In thismanner, a repair device 140, having similar structural features of therepair devices described in the various embodiments herein, may beemployed for fixating tendon 5 (or any soft tissue) to bone 19.

With respect to FIG. 11, another embodiment of a repair device system131 for fixating soft tissue 5 to bone 19 is provided. Similar to theprevious embodiments for fixating soft tissue to bone, the repair devicesystem 131 may include a carrier member 133, multiple anchors 135, andone or more bone anchors 137. In this embodiment, the carrier member 133may include upper pad portions 139 and lower pad portions 141 (or upperand lower substrates/carrier members), the upper pad portions 139 beingseparate and discrete from the lower pad portions 141. Each of the upperand lower pad portions 139, 141 may be a substantially flat structure.Further, each of the upper and lower pad portions 139, 141 may be amulti-cellular structure that may be seamless and monolithic (singlepiece).

As in the previous embodiments, each pad portion of the upper and lowerpad portions 139, 141 may include one or more slots 143, the slots 143being defined as apertures, holes, and/or notches. For example, theslots 143 defined in a given pad portion may include a central slot 145and opposing side slots 147, the opposing side slots 147 being similarto a notch formed in opposing peripheral sides 149 of the pad portion.Each pad portion of the respective upper and lower pad portions 139, 141may be interconnected to an adjacent pad portion with struts 151.Further, the central slot 145 and side slots 147 are sized andconfigured to receive portions of the anchors 135. The anchors 135 maybe u-shaped with a mid-upper portion 153 and legs 155 extending from themid-upper portion 153. Further, the anchors 135 may each include a tine157 extending downward between the legs 155 and within a common plane ofthe legs 155.

The anchors 135 may be manipulated to engage the upper and lower padportions 139, 142 with the soft tissue 5 therebetween, as depicted inFIGS. 11A and 11B, with an anvil 159 depicted in FIG. 11. The anvil 159may include multiple anvil beds 161 defined therein. Each anvil bed 161may extend from an outer end 171 to and inner end 173 with a downwardslope from the outer end 171 to a ramp toward the inner end 173 of theanvil bed 161. Further, each anvil bed 161 may define a groove 163 (FIG.11) therein to capture ends of the legs 155 and manipulate them througha precise orientation. In this manner, each anvil bed 161 extends with aradial component sized and configured to curl the legs 155 of theanchors 135. Further, in another embodiment, each anvil bed 161 may becanted relative to a longitudinal axis 165 of the anvil 159. As such,the legs 155 of the anchor 135 may be manipulated to curl and pass byeach other in an over-lapping manner or side-by-side, as depicted inFIGS. 11A and 11B. With this arrangement, legs 155 of the anchor 135 mayextend alongside opposing side slots 147 of the upper and lower padportions 139, 141 and curl around a bottom surface 167 of the lower padportions 141 and through the central slot 145 of the lower pad portions141. Further, as depicted, each pair of the canted anvil beds 161manipulate the legs 155 of each anchor 135 to pass through the centralslot 145 so that the legs 155 grab and bundle a portion of the softtissue 5 in a side-by-side manner. Further, the groove 163 (FIG. 11) ineach anvil bed 161 facilitates a pre-determined curl in the legs 155 ofthe anchors 135. Such anchors 135 and carrier member 133 may be securedto the soft tissue 5 with, for example, a delivery tool having an anchorcartridge (not shown) coupled to the anvil 159.

With reference to FIGS. 11 and 12, upon the anchors 135 securing thecarrier member 133 to the soft tissue 5, the bone anchor 137, such as abone screw or the like, may be inserted through, for example, thecentral slot 145 adjacent one end of each of the upper and lower padportions 139, 141 and then into a pre-drilled hole in the bone 19. Inone embodiment, the carrier member 133 may include a bone engagingportion 169 such that the pad portion at one common end of each of theupper and lower pad portions 139, 141 acts as the bone engaging portion169. As such, in this embodiment, the central slot 145 at the one end ofthe upper and lower pad portions 139, 141 may act as the hole defined inthe bone engaging portion 169 of the carrier member 133. In anotherembodiment, the bone engaging portion 169 may be an extension from theupper and lower pad portions 139, 141, similar to the extended boneengaging portion of FIG. 10

With respect to FIG. 13, another embodiment of a flexible member 170coupled to multiple anchors 172 is provided. Such flexible member 170and anchor 172 arrangement of this embodiment may be employed as acomponent or portion to be added or replace the flexible member/anchorarrangement of the various repair devices set forth herein. The flexiblemember in this embodiment may be one or more filaments configured to beintegrated with the anchors 172, the anchors shown simplistically withtwo tines 174 extending from the intermediate portion 176 and betweenthe first and second legs 178, 180. For example, in one embodiment, theanchors 172 may be the same or similar to the anchor depicted in FIG. 5.

In this embodiment, the flexible member 170 having the one or morefilaments may be a single filament 182. The single filament 182 may besystematically wrapped around the anchors 172 in a manner that coupleseach of the anchors 172 together. Further, for simplistic purposes, thefilament 182 is depicted as wrapping around the anchors 172 with fewerrotations than that which the single filament is preferably wrappedaround the anchors. For example, the filament 182 may be wrapped aroundpairs or sets of the anchors 172 with two, three or more rotations and,preferably, the anchors 172 may be wrapped with at least five rotationsor wraps around the pairs or sets of anchors.

In one embodiment, the filament 182 may be wrapped around theintermediate portion 176 of the anchors 172 and between the two tines174 of each of the anchors 172. One method for wrapping the filament 182around the anchors 172 may include systematically wrapping the pairs orsets of anchors 172 beginning at inner adjacent anchors 184 and thenwrapping around other anchors 172 adjacent and outward the inneradjacent anchors 184. As depicted, the anchors 172, in one example, mayinclude a first anchor 186, a second anchor 188, a third anchor 190, afourth anchor 192, a fifth anchor 194, and a sixth anchor 196. Thefilament 182 may first be wrapped around the intermediate portion 176and between the two tines 174 of the inner adjacent anchors 184 or thirdand fourth anchors 190, 192. The filament 182 may then further bewrapped around a first anchor set 198 or the second and fifth anchors188, 194 while also wrapping over the third and fourth anchors 190, 192.The filament 182 may then continue and be further wrapped around theintermediate portion 176 between the two tines 174 of a second anchorset 200 or the first and sixth anchor 186, 196, while also wrappingaround the other anchors 172.

In one embodiment, the wraps around the third and fourth anchors 190,192, the second and fifth anchors 188, 194, and the first and sixthanchors 186, 196 may include five rotations or wraps of the filament182. In another embodiment, in the wrapping process and upon firstarriving to a given anchor, the wrapping of the anchors 172 may includewrapping the filament 182 completely around each intermediate portion176 of a given anchor before continuing the wrapping of a given pair orset of anchors 172. In still another embodiment, upon completing thewraps of the anchors 172, the fourth, fifth, and sixth anchors 192, 194,196 may be simultaneously rotated, as indicated by arrow 202, with oneor more rotations so as to result in a twist in the filament between thethird and fourth anchors 190, 192. In this manner, the flexible member170 may be employed with the single filament 182 integrated with theanchors 172, the flexible member 170 and anchor 172 arrangement to beemployed as a component of a repair device of any one of the variousembodiments set forth herein.

In one embodiment, the filament 182 may be a polymeric filament or apolymeric fiber. The polymeric filament or fiber may be a polyethylenematerial, such as ultra-high-molecular-weight polyethylene (“UHMWPE”), apolyester material, a polypropylene material, or the like. In anotherembodiment, the polymeric filament or fiber may be a bioresorbablematerial, such as polylactide (“PLA”), polycaprolactone (“PCL”),polydioxanone (“PDX”), or the like, or any other suitable bioresorbablematerial as known to one of ordinary skill in the art. Such a singlefilament or fiber may include a woven, braided, or a single strandconfiguration.

With respect to FIGS. 14 and 14A, a flexible wrap member 204 as acomponent or portion of a repair device, according to another embodimentof the present invention, is provided.

The flexible wrap member 204 may be sized and configured to be wrappedaround the soft tissue 5 prior to receiving the remaining portions of arepair device, described in further detail hereafter. The flexible wrapmember 204 may also be positioned to surround and wrap over the softtissue repair site. The flexible wrap member 204 is flexible and may bereadily manipulated to wrap around the soft tissue, as indicated byarrows 206.

The flexible wrap member 204 may include an inner surface 208 and anouter surface 210 defined by a periphery 212 having a depth 214.Further, the flexible wrap member 204 may include a length 216 and awidth 218, the length 216 being elongated. The width 218 may be sizedwith about a dimension of at least a circumference of the soft tissue 5to which the flexible wrap member 204 is to surround so that theflexible wrap member 204 may completely surround the soft tissue 5. Inone embodiment, the width 218 of the flexible wrap member 204 may belarger than the circumference of the soft tissue 5 so that the flexiblewrap member 204 overlaps itself upon being wrapped around the softtissue 5.

In one embodiment, the flexible wrap member 204 may be porous withsimilar structural characteristics of the flexible member described inFIG. 2. In another embodiment, the flexible wrap member 204 may includepores 220 sized and configured to induce tissue growth, the pores 220being in the range of about 50 to 250 microns. The pores 220 may extendthrough the depth 214 of the flexible wrap member 204 or may be openingsor recesses within the surface. In either case, the pores 220 may besized to encourage cell attachment and tissue ingrowth into the flexiblewrap member 204. In another embodiment, the outer surface 210 of theflexible wrap member 204 may include a non-porous surface. In anotherembodiment, the flexible wrap member 204 may include an additional layer222 of material to form the outer surface 210 of the flexible wrapmember 204 that is non-porous. In another embodiment, the outer surface210 of the flexible wrap member 204 may include pores, but the poresdefined in the outer surface 210 are less than 50 microns or the poresdefined in the outer surface 210 may be sized to inhibit or limit tissueingrowth.

With respect to FIGS. 14 and 15, the flexible wrap member 204 may beemployed with the before-discussed components of a repair device 224.For example, in one embodiment, the repair device 224 may include theflexible wrap member 204, multiple anchors 172, and one or more rigidmembers, such as a single rigid member 134 (see also FIG. 9). Theflexible wrap member 204 may be positioned within the cradle portion 26(FIG. 7) of the delivery device, the cradle portion 26 also holding therigid member 134 such that the rigid member 134 is disposed between thebed surface 28 (FIG. 7) of the cradle portion 26 and the flexible wrapmember 204. The soft tissue 5, such as a severed tendon, may then bepositioned within the cradle portion 26 and over the flexible wrapmember 204. The flexible wrap member 204 may then be wrapped around thesevered tendon, as indicated by arrow 206. The multiple anchors 172,held within the cartridge 24 (FIG. 1) of the delivery device 22, maythen be actuated to be forced from the cartridge 24 and into theflexible wrap member 204, through the soft tissue 5 and through opposingnotches 136 defined in the rigid member 134. The multiple anchors 172then engage the canted anvil buckets 112 (FIG. 7) defined in the bedsurface 28 of the cradle portion 26 to be forced to curl throughopenings 138 (FIG. 9) defined in the rigid member 134 such that thecurled legs of the anchors 172 extend back through the flexible wrapmember 204 and into the soft tissue 5 (similar to that depicted in FIG.6B). In one embodiment, the multiple anchors 172 may be coupled by theflexible member defining the filament 182 (see also FIG. 13). In anotherembodiment, the flexible wrap member 204 may act as the variousembodiments described herein for a flexible member such that thecartridge 24 (FIG. 1) may not hold a pre-positioned flexible member orfilament 182 therewith.

As set forth, the flexible wrap member 204 may be positioned around thesoft tissue 5 prior to coupling anchors 172 to the rigid member 134 andthe flexible wrap member 204. As such, the flexible wrap member 204 mayact as a strength member to the severed soft tissue or tendon 5.Further, the flexible wrap member 204 may act as an ingrowth substratefor inducing tissue growth through and along the flexible wrap member204 so as to bridge any gap that may occur between the severed tendonends. In another embodiment, the flexible wrap member 204 may bepositioned around the severed tendon subsequent to fixating a givenrepair device to the severed tendon so as to act as an ingrowthsubstrate along the tendon.

With respect to FIG. 16, a retrieving device 226 for retrieving a tendonthat has migrated or withdrawn from the ruptured or severed site may beprovided. The retrieving device 226 may be deployable from a sheath 228and configured to retrieve a tendon percutaneously from the anatomy withminimal cuts to the anatomy. For example, a severed Achilles tendonportion may withdraw itself further into its tendon sheath from thepoint of the sever at a tendon stump. The physician may advance theretrieving device 226 percutaneously toward the severed tendon portion229 and, once the end of the sheath 228 is adjacent the tendon portion229, the physician may deploy the retrieving device 226, grab the tendonportion 229 with clamps 230 of the retrieving device 226 and pull thetendon portion 229 adjacent the tendon stump 231.

Now with reference to FIGS. 16 and 17, a repair device 232 for attachingto soft tissue at a repair site of the soft tissue is provided. Therepair device 232 of this embodiment may be employed with any suitablesevered or ruptured tendon. For example, as depicted, a severed tendonmay be a severed Achilles tendon including a tendon portion 229, such asthe Achilles tendon portion, and a tendon stump 231, such as theAchilles tendon stump, the tendon stump 231 extending from a boneportion 233, such as the calcaneus bone portion.

The repair device 232 employed with the severed Achilles tendon may besimilar to the previous repair devices and the variations of componentsdescribed herein. For example, the repair device 232 may include theflexible wrap member 204 configured to wrap around the severed tendonwith an upper rigid substrate 234 and a lower rigid member 236 coupledtogether with anchors 172 and to sandwich the flexible wrap member 204and severed tendon therebetween. The flexible wrap member 204 may besimilar to that described and depicted relative to FIGS. 14 and 14A. Theupper rigid substrate 234 may be similar to the upper plate memberdescribed in FIG. 8. The lower rigid member 236 may be similar to thesingle rigid member described in FIG. 9. Further, as described inprevious embodiments, the legs 240 of the anchors 172 may extend throughnotches 238 defined in the lower rigid member 236 to engage canted anvilbuckets 112 defined in the cradle portion 26 to urge the legs 240 tocurl in a controlled manner and to extend and wrap around the lowerrigid member 236 and through openings defined in the lower rigid member236.

Further, in one embodiment, the repair device 232 may include a firstbone coupling portion 242 and a second bone coupling portion 244. Forexample, the upper rigid substrate 234 may include the first bonecoupling portion 242 and the lower rigid member 236 may include thesecond bone coupling portion 244. Each of the first and second bonecoupling portions 242, 244 may include a flexible filament 246 or suturelike member (shown in outline form) with a bone anchor attachmentportion 248. Such bone anchor attachment portion 248 may be sized andconfigured to attach any suitable bone anchor. In this manner, therepair device 232 may be configured to be further secured to the boneportion 233 adjacent the tendon stump portion.

Now with reference to FIGS. 18, 18A and 19, another embodiment of arepair device 250 for attaching to a severed tendon, such as theAchilles tendon, is provided. In this embodiment, the repair device 250may include a first part 252 and a second part 254 that may be synchedtogether with a synch portion 256. The first part 252 may include afirst side plate 258 and a second side plate 260, the first and secondside plates 258, 260 defining openings/notches sized and configured toreceive anchors 262 for coupling the first and second side plates 258,260 together and sandwiching the tendon portion 229 therebetween.Similarly, the second part 254 may include a third side plate 264 and afourth side plate (not shown), the third and fourth side plates definingopenings sized and configured to receive anchors 262 for coupling thethird and fourth side plates together with the tendon stump 231sandwiched therebetween. The anchors 262 may be similar to previouslydescribed anchors with a u-shaped configuration and legs that curl andwrap around the opposing second side plate 260 and fourth side plate(not shown) of the respective first and second parts 252, 254 of therepair device 250. In this manner, each of the first and second parts252, 254 may be coupled to each other similar to the opposing membersand anchor arrangements of previous embodiments (see FIG. 6B).

In addition, as depicted, the first and second parts 252, 254 may eachdefine openings to receive the anchors 262 aligned in multiple rows forcoupling the respective opposing plates. In another embodiment, theanchors 262 may be aligned in a single row in the first and second parts252, 254 to couple the respective opposing plates, similar to theprevious embodiments. In still another embodiment, the first and secondparts 252, 254 may each define openings for receiving the anchors 262 ina staggered arrangement to couple the respective opposing plates.

As set forth, the repair device 250 may include a synch portion 256. Thesynch portion 256 may include a draw string 266 wound or extendingthrough eyelets 268 positioned on the first and second parts 252, 254 ofthe repair device 250. In one embodiment, the eyelets 268 may bepositioned on one side of each of the first side plate 258 and thesecond side plate 260 as well as on one side of each of the third sideplate 264 and the fourth plate (not shown) such that the one side of thefirst part 252 is positioned adjacent to the one side of the second part254. The draw string 266 may extend through each of the eyelets 268 to apull portion 272. Upon the first and second parts 252, 254 being securedto the severed tendon, the draw string 266 may draw the respective firstand second parts 252, 254 toward each other by pulling the pull portion272. In other words, the draw string 266 may be drawn to pull the firstpart 252 toward the bone portion 233 and the second part 254.

A method of repairing a severed tendon with the repair device 250 willnow be described. Similar to that described in the previous embodiment,the tendon portion may be retrieved and positioned by a physician with aretrieving device 226 (FIG. 16) so as to position the tendon portion 229adjacent to the tendon stump 231. Further, similar to previousembodiments described herein, the physician may then secure the firstpart 252 to the tendon portion 229 with a delivery device having acradle portion and a cartridge. For example, the physician may lay thetendon portion 229 within the cradle portion of the delivery device andover the second side plate 260 positioned over the bed surface of thecradle portion. Also, the cartridge of the delivery device may hold thefirst side plate 258 and the anchors 262. Upon the physician beingsatisfied with the position of the tendon portion 229 in the cradleportion, the delivery device may then be actuated to force the anchors262 from the cartridge to continue through the first side plate 258 andtendon portion 229 and be forced against anvil buckets in the bedsurface of the cradle portion. The anchors 262 may then be wrappedaround the second side plate 260 and through openings defined in thesecond side plate 260 in a curled manner to secure the first part 252 ofthe repair device 250 to the tendon portion 229. In a similar manner,the physician may then secure the second part 254 of the repair device250 to the tendon stump 231. Once each of the first part 252 and secondpart 254 is attached to the severed tendon, the physician may synch ordraw the draw string 266 by pulling on the pull portion 272 to pull thefirst part 252 toward the second part 254 or the bone portion 233 sothat the severed end of the tendon portion 229 abuts the severed end ofthe tendon stump 231 or the bone portion 233. The physician may thensecure the draw string 266 in the pulled position to maintain the tendonends in an abutting relationship. Such securing of the draw string 266may be employed with a locking mechanism 274 positioned with or adjacentto the last eyelet that the draw string 266 passes through. The lockingmechanism 274 may be any suitable locking mechanism, such as a buckletype arrangement as depicted in FIG. 19A, so that the pulled draw string266 is maintained to the pulled position. The physician may then furthersecure the draw string 266 with a knot or the like.

Now with respect to FIGS. 20, 21, and 21A, a tissue growth member 280 ortissue strengthening member configured to be positioned within thesevered tendon ends 282 of a tendon 284 at a repair site 288 isprovided. Such tissue growth member 280 may be provided to the severedtendon ends 282 prior to securing the ends together with any one of therepair devices described herein. The tissue growth member 280 may be inthe form of multiple rods, strips, or fibers, and/or gel, orcombinations thereof. Such rods, strips, fibers and/or gel may bemanually positioned by the physician with tweezers or the like so as toposition the tissue growth member 280 alongside and within the tendonfibers 286. In one embodiment, the tissue growth member 280 may be apolymeric material. In another embodiment, the tissue growth member 280may include a chemical inducing substance to enhance and induce tissuegrowth between the ruptured or severed tendon fibers 286 at and adjacentthe repair site 288. In another embodiment, the rods, strips, fibersand/or gel may include collagen. In another embodiment, the rods,strips, fibers and/or gel may include a chemical for drug delivery. Inanother embodiment, the rods, strips, fibers and/or gel may be porous.Upon the tissue growth member 280 being added to the repair site 288,the physician may then fixate the tendon ends 282 with a repair device.

With reference to FIG. 22, another embodiment of a repair device 300,depicted in a pre-deployed state, including first and second anchors302, 304 positioned opposite first and second plate members 306, 308, isprovided. The first and second anchors 302, 304 may include an anchorcoupling portion 310 and the first and second plate members 306, 308 mayinclude a plate coupling portion 312. In the pre-deployed state, thefirst and second anchors 302, 304 may be positioned within a cartridge322 and the first and second plate members 306, 308 may be positionedwithin a cradle portion 324, the cartridge 322 and cradle portion 324being portions of a delivery device 320. The cartridge 322 and cradleportion 324 linearly moveable relative to each other, but maintaining aposition along a delivery device axis 326. With the first and secondplate members 306, 308 positioned in the cradle portion 324, soft tissue5, such as tendon and/or ligament, may be positioned over the first andsecond plate members 306, 308 with severed first and second ends 11, 13of the soft tissue 5 positioned over the plate coupling portion 312. Thecartridge 322 with the first and second anchors 302, 304 disposedtherein may then be positioned adjacent the soft tissue 5. The deliverydevice 320 may then be actuated so that the first and second anchors302, 304 move from a pre-deployed state to a deployed state (not shown).

In this embodiment, the first and second plate members 306, 308 may besimilar to, and perform similar functions as, the before-described rigidmembers. Further, in one embodiment, the first and second plate members306, 308 may elongate (so as to be moveable to a longitudinally longerstate) with a force applied thereto. Similarly, the first and secondanchors 302, 304 define structural characteristics that may beconfigured to elongate. The anchor coupling portion 310 and the platecoupling portion 312 may be a flexible element and may substantiallyresist longitudinal elongation. In this manner, upon the repair device300 being deployed and anchored to soft tissue 5, the first and secondplate members 306, 308 and anchors 302, 304 may elongate while theanchor coupling portion 310 and the plate coupling portion 312 maysubstantially resist elongation as the soft tissue 5 is exercised and/ora force is applied to the soft tissue 5 so as to elongate the softtissue 5. As such, the first anchor 302 and first plate member 306define a first portion 314 or first zone of the repair device 300 thatmay elongate and the second anchor 304 and the second plate member 308define a second portion 316 or a second zone of the repair device 300that may elongate while the anchor coupling portion 310 and the platecoupling portion 312 define an intermediate portion 318 or middleportion or mid zone of the repair device 300 that substantially resistselongation.

Now with reference to FIGS. 23 and 24, details of the repair device 300will now be described, FIG. 23 depicting the repair device 300 in apre-deployed state and FIG. 24 depicting, for example, the first anchor302 in a pre-formed state. The first and second anchors 302, 304 of therepair device 300 may each include a monolithic and seamlessmulti-cellular structure, the structure of each anchor including a body330 and multiple legs 332, having a bug-like or arachnid appearance.Further, as positioned in a pre-deployed state, the first and secondanchors 302, 304 may be oriented and aligned relative to each other todefine an anchor longitudinal axis 334 extending along the anchorcoupling portion 310 and through the first and second anchors 302, 304.The structure of the body 330 of each anchor may include a continuousinterconnected structure (arcuate and linear) extending in anon-symmetrical manner with major portions of the body 330 extendingtransversely relative to the anchor longitudinal axis 334.

For example, the first anchor 302 may include the body 330 having anelongated central portion 336 and a head portion 338 with multiple outerextensions 340 extending outward from the central portion 336 andmultiple inner extensions 342 extending from the head portion 338. Eachof the elongated central portion 336, head portion 338, and outer andinner extensions 340, 342 may be substantially planar relative to eachother. The legs 332 may extend generally perpendicular relative to theplanar body 330, as depicted in FIG. 23. The second anchor 304 may besubstantially similar to the first anchor 302, but rotated so that thehead portion 338 and inner extensions 342 of the second anchor areadjacent the head portion 338 and inner extensions 342 of the firstanchor 302.

As depicted in the top view of the first anchor 302 in FIG. 24 (andoriented relative to the anchor longitudinal axis 334), the elongatedcentral portion 336 may include elongated lengths 344 extendinggenerally parallel to each other with arcuate portions 346 at ends ofthe lengths to define an elongated elliptical shape. Further, theelongated central portion 336 may define an elongated opening 348therein. The elongated lengths 344 of the elongated central portion 336may extend transverse relative to the anchor longitudinal axis 334,which may extend upward from left-to-right. The head portion 338 mayextend from one of the arcuate portions 346 with a tear-drop shape orthe like, the head portion 338 defining a head opening therein. The headportion 338 may generally extend transversely relative to the anchorlongitudinal axis 334 in a downward direction from left-to-right. Theinner extensions 342 may extend in a curved manner and/or a straightmanner from the head portion 338 and generally transverse relative tothe anchor longitudinal axis 334. At the opposite end of the body 330,the outer extensions 340 may extend from the elongated central portion336 in an arcuate and/or straight manner and may also extend generallytransverse relative to the anchor longitudinal axis 334.

With respect to FIGS. 23 and 24, as previously set forth, each of thefirst anchor 302 and the second anchor 304 may include multiple legs332. Each of the legs 332 may be integral and monolithic with the body330 of a given anchor. In one embodiment, each anchor may include sixlegs, of which two legs 332 may extend from ends of the outer extensions340, two legs 332 may extend from ends of the inner extensions 342, andtwo legs 332 may extend from the elongated lengths 344 of the elongatedcentral portion 336 of the body 330. Each leg 332 may extend between afree end 352 and a base 354 and may include one or more tapers along atleast a portion of a length of each leg. In one embodiment, each leg 332may include a base portion 356, an intermediate portion 358, a bendingportion 360, and an end portion 362. The base portion 356 may include asubstantially uniform cross-section or slightly taper, the intermediateportion 358 may taper from the base portion 356 to the bending portion360, and the bending portion 360 may slightly taper from theintermediate portion 358 to the end portion 362. The end portion 362 maytaper such that the free end 352 comes to a point and/or an edge 364extending a distance. The distance may be a thickness or depth of thesheet material from which the anchor is cut.

As depicted in FIG. 24, the first and second anchors 302, 304 may beformed from sheet material, such as stainless steel, titanium, orNitinol, or any other suitable material. The first and second anchors302, 304 may be, for example, laser cut from the sheet material, or cututilizing other suitable methods known in the art. Upon cutting theanchors from the material, the legs 332 may then be bent inpredetermined directions, shown by arrows 366, such that the legs arebent (into the paper) to extend substantially orthogonal relative to thebody 330 of the anchors. Such bending of the anchors may be accomplishedusing fixtures to precisely bend the anchors. In the case of the Nitinolmaterial, the legs may be held in the position desired and thenheat-set, as known by one of ordinary skill in the art. The anchors mayalso undergo a polishing process, such as electo or chemicalpolishing/etching, or any other process known in the art.

Referring back to FIG. 23, upon the first and second anchors 302, 304being formed, the anchor coupling portion 310 may be applied thereto.The anchor coupling portion 310 may be configured to couple the firstand second anchors 302, 304 together at a pre-determined distance fromeach other. The anchor coupling portion 310 may be in the form of a bandor ribbon. The anchor coupling portion 310 may be flexible so as toallow the first and second anchors 302, 304 to move to differentorientations relative to each other, and/or to make a tight turn arounda radius or the like, and/or to allow the first and second anchors 302,304 to move closer to each other relative to the pre-determineddistance. Further, the anchor coupling portion 310 may be sized andconfigured to substantially resist elongation beyond the pre-determineddistance. The anchor coupling portion 310 may be in the form of one ormore filaments 368 that may be threaded through, for example, the headopening 350 of each head portion 338 of the first and second anchors302, 304, or any other suitable aperture of the first and second anchors302, 304.

In one embodiment, the anchor coupling portion 310 and the platecoupling portion 312 may be a polymeric filament or a polymeric fiberwith one or more filaments/fibers. The polymeric filament or fiber maybe a polyethylene material, such as ultra-high-molecular-weightpolyethylene (“UHMWPE”), a polyester material, a polypropylene material,or the like. In another embodiment, the polymeric filament or fiber maybe a bioresorbable material, such as polylactide (“PLA”),polycaprolactone (“PCL”), polydioxanone (“PDX”), or the like, or anyother suitable bioresorbable material as known to one of ordinary skillin the art. Such a single filament or fiber may include a woven,braided, strands wound in a side-by-side configuration, or strands woundside-by-side and twisted configuration.

Now with reference to FIGS. 23 and 25, the repair device 300 may alsoinclude the first and second plate members 306, 308. Each of the platemembers may be a monolithic structure. The first and second platemembers 306, 308 may be coupled together with the plate coupling portion312 so that the plates are oriented relative to each other to define aplate longitudinal axis 382. Further, each of the plate members mayinclude a plate portion 370 and multiple tines 372. The plate portion370 may define a periphery 374 with notches 376 defined therein.Further, the plate portion 370 may include multiple openings 378 definedtherein such that the plate portion 370 defines a multi-cellularstructure. The openings 378 and notches 376 defined in each plateportion 370 may be sized and configured to receive the legs 332 of thefirst and second anchors 302, 304 so as to inter-lock the first andsecond anchors 302, 304 to the respective first and second plate members306, 308, discussed in further detail herein. The multiple tines 372 mayextend substantially orthogonal or canted relative to the plate portion370, as depicted in FIG. 23. As depicted in FIG. 25, the first andsecond plate members 306, 308 may be formed from sheet material suchthat, in the pre-formed state, the tines 372 may be within the sameplane as the plate portion 370. Once cut from the sheet material, thetines 372 may be bent to extend substantially orthogonal from theperiphery of the plate portion 370, similar to that depicted in FIG. 23,and utilizing similar methods set forth for bending the legs 332 of theanchors.

As set forth, the first and second plate members 306, 308 may be coupledtogether with a plate coupling portion 312. Such plate coupling portion312 may be sized and configured to position the first and second platemembers 306, 308 a predetermined distance from each other. The platecoupling portion 312 may extend between respective inner openings 380defined in the respective first and second plate members 306, 308. Theplate coupling portion 312 may include similar structuralcharacteristics as that described for the anchor coupling portion 310.For example, the plate coupling portion 312 may be flexible, butsubstantially resist elongation. In one embodiment, the plate couplingportion 312 may be one or more filaments. In another embodiment, theplate coupling portion may be in the form of a band. In anotherembodiment, the one or more filaments may be wrapped to exhibit a bandconfiguration as the plate coupling portion 312.

With reference to FIGS. 26 and 27, alignment of the legs 332 of thefirst and second anchors 302, 304 relative to the notches 376 andopenings 378 of the respective first and second plate members 306, 308is depicted. For example, inner side legs 384 of the first anchor 302may correspond with inner side notches 386 of the first plate member306. Similarly, outer side legs 388 of the first anchor 302 maycorrespond with outer side notches 390 of the first plate member 306.Further, middle legs 392 of the first anchor 302 may correspond with twoof the openings 378 defined in the first plate member 306. A similararrangement may be utilized with the legs 332 of the second anchor 304relative to the second plate member 308.

As previously set forth, the first and second plate members 306, 308 maybe configured to be positioned within a cradle portion 324. The cradleportion 324 may include a bed surface 394 with an inset recess 396defined therein. The inset recess 396 may define an inset surface 398with anvil buckets 400 defined therein. The inset recess 396 may besized to act as a guide so that the periphery 374 of the first andsecond plate members 306, 308 may be appropriately oriented andpositioned within the cradle portion 324. Similar to previousembodiments, the anvil buckets 400 may include a bottom surface 402having a downward slope 404 and an upward slope 406 and an upstandingwall 408 or functional wall that may be oriented, sized and configuredto manipulate a direction for bending the legs 332 to be curled or bentthrough a pre-determined opening 378 defined in the plate members. FIG.27A illustrates the first plate member 306 positioned within the insetrecess 396 of the bed surface 394, illustrating the relationship of thenotches 376 and openings 378 of the first plate member 306 relative tothe anvil buckets 400.

Further, with respect to FIGS. 26, 27, and 27A, the outer side legs 388correspond with the outer side notches 386, which in turn correspondwith the outer side anvil buckets 410, the outer side buckets 410configured to manipulate the legs 332 to wrap around a portion of theplate portion 370 and through one of the openings 378 of the plateportion 370. Similarly, the inner side legs 384 correspond with theinner side notches 386, which in turn correspond with the inner sideanvil buckets 412, the inner side anvil buckets 412 configured tomanipulate the legs 332 to wrap around a portion of the plate portion370 and through one of the openings 378. The middle legs 392 wrapcorrespond with middle anvil buckets 414 and extend through some of themiddle openings 378 defined in the plate member, as depicted. In thismanner, the downward and upward slopes 404, 406 of the anvil buckets 400with the upstanding functional wall 408 of each anvil bucket 400 maymanipulate the legs 332 to wrap and secure the first and second anchors302, 304 to the respective first and second plate members 306, 308.

In another embodiment, each leg 332 of the first anchor 302 ispositioned laterally relative to a cradle longitudinal axis 416 (orplate longitudinal axis 382) at a different lateral distance than anyother leg 332 of the first anchor 302. Similarly, each leg 332 of thesecond anchor 304 is positioned laterally relative to the cradlelongitudinal axis 416 at a different lateral distance than any other leg332 of the second anchor 304. As such, upon anchoring the repair device300 to soft tissue (not shown), the legs 332 will wrap and bundledifferent longitudinally extending tendon fibers (not shown) relative toeach of the first and second anchors 302, 304. In another embodiment,the orientation of each anvil bucket pair is different than theorientation of any other anvil bucket pair that corresponds with thelegs 332 of either the first anchor 302 or the second anchor 304. Inthis manner, the holding strength to the longitudinally extending tendonfibers will be greater than if the legs were bent from the same lateraldistance from the cradle longitudinal axis 416 and at the sameorientation.

With respect to FIG. 28, a perspective view of an elongated handleassembly 420 with the cartridge 322 disengaged from the elongated handleassembly 420, is provided. In one embodiment, the elongated handleassembly 420 may include the cradle portion 324, a slide guide 422, aslider 424 and a turn knob 426 for linearly moving the slider 424relative to the slide guide 422. The slider 424 may include a worm drive428 and a pusher block housing 430 coupled thereto. The slider 424 mayalso include a proximal connecting portion 432 for connecting to atrigger handle 450 (FIG. 33). The cradle portion 324 may be fixedlycoupled to the slide guide 422. Further, the cradle portion 324 includesthe bed surface 394 and a channel shape oriented and configured toreceive severed or lacerated soft tissue portions, such as tendon and/orligament. The cradle portion 324 may be oriented to receive the softtissue portions oriented longitudinally and parallel with the cradleaxis 416. Further, the cradle axis 416 extends orthogonal to thedelivery device axis 326 of the elongated handle assembly 420. Suchdelivery device axis 326 of the elongated handle assembly 420 may extendalong or through a pusher shaft axis 452 (FIG. 32A) co-aligned orco-axial with delivery device axis 326, discussed in further detailhereafter.

With respect to FIGS. 28 and 29, in one embodiment, the cartridge 322may be removeably attachable to the pusher block housing 430. Thecartridge 322 may include attachment portions in the form of protrusionswith a ramp portion 434 and a holding portion 436, the protrusionsextending from opposing lateral sides of the cartridge 322. The pusherblock housing 430 may include clips 438 coupled to opposing lateralsides of the pusher block housing 430. The cartridge 322 may be attachedby simply manually positioning the cartridge 322 such that the clips 438move up a corresponding ramp portion 434 and hook to the holding portion436 of each protrusion. With this arrangement, the cartridge 322 may bepositioned against a distal end of the pusher block housing 430.

The cartridge 322 may also include a base alignment portion 440 definingopposing grooves 442, best shown in rear and front views of thecartridge in respective FIGS. 30 and 31. The opposing grooves 442defined in the base alignment portion 440 of the cartridge 322 may besized and configured to align and correspond with a channel 444 (FIG.28) defined in the cradle portion 324. Such base alignment portionfacilitates the cartridge 322 to be appropriately aligned with thecradle portion 324 so that the first and second anchors 302, 304 arealigned with the first and second plate members 306, 308 (see FIG. 36).

In another embodiment, the cartridge 322 includes a contoured aperture446 defined in a central portion of the cartridge 322 and extendingthrough the cartridge 322. The contoured aperture 446 may be shaped,sized and configured to receive the first and second anchors 302, 304(not shown) such that the contoured aperture 446 defines a correspondingshape or profile of the periphery of the first and second anchors 302,304. As depicted in FIG. 28, the rear side of the cartridge 322 mayinclude an additional recess 448 extending partially into the rear sideof the cartridge 322. Such additional recess 448 may be sized to receivean enlarged coupling between a push rod 454 and a pusher block 456 (seeFIG. 32A), upon the pusher block 456 being moved into the cartridge topush the first and second anchors 302, 304 from the cartridge 322.

Now with reference to FIGS. 32, 32A, and 32B, further description of theelongated handle assembly 420 with the cartridge 322 engaged theretowill now be provided. As previously set forth, the elongated handleassembly 420 may include the slide guide 422 fixed to the cradle portion324. The cradle portion 324 may be fixed to the slide guide 422 via oneor more connector plates 458 along an underside of the slide guide 422and cradle portion 324. By rotating the turn knob 426, as shown withrotational arrow 460, the worm drive 428 is activated to move the slider424 and pusher block housing 430 as well as the cartridge 322 toward thecradle portion 324. Opposite rotation of the turn knob 426 will move thepusher block housing 430 and cartridge 322 away from the cradle portion324.

As depicted in the cross-sectional views of FIGS. 32A and 32B, theslider includes the elongated push rod 454, defining shaft axis 452,extending through the turn knob 426 and worm drive 428 with opposingends extending between a push button 462 and a pusher block 456. At theproximal side, the push rod 454 may be coupled and fixed to the pushbutton 462. Further, the push rod 454 may be spring biased toward aproximal position with a return spring 464 biased between a portion ofthe proximal connecting portion 432 or slider 424 and a non-exposedsurface of the push button 462.

With respect to FIGS. 32A, 32B, and 33, at the distal end of the pushrod 454, the push rod 454 may be coupled to the pusher block 456 anddisposed within the pusher block housing 430. Upon coupling the triggerhandle 450 to the proximal connecting portion 432 at a proximal side ofthe elongated handle assembly 420, the trigger handle 450 may beactuated to force the push button 462, and thus, the push rod 454 apredetermined distal distance, thereby, forcing the push rod 454 forwardthe pre-determined distance with a pre-determined amount of force so asto move the pusher block 456 into the cartridge 322. A detaileddescription of a suitable trigger handle, capable of providing the forcenecessary to actuate the push rod 454, is disclosed in U.S. Pat. No.5,344,061, the disclosure of which is hereby incorporated herein byreference in its entirety.

With respect to FIGS. 32B and 34, the pusher block 456 holds a contouredexternal surface 468. Such contoured external surface 468 may be shaped,sized, and configured to move through the contoured aperture 446 definedin the cartridge 322 (see FIG. 29). Further, the pusher block 456 mayhold a cavity at its rear side (not shown) to couple to the push rod454, the cavity defined within a central portion of the pusher block456. The pusher block 456 may include an enlarged portion 470 to holdthe push rod 454 therein.

With respect to FIGS. 32 and 35, description of the steps of repairingsevered or lacerated soft tissue will now be described. If not alreadypre-engaged, the physician may engage the cartridge 322 against thedistal end of the pusher block housing 430 so as to be removablyattached thereto via the opposing clips 438, as previously discussed.The physician may place two severed end portions within the cradleportion 324 and over the first and second plate members 306, 308 suchthat the severed ends are positioned over the plate coupling portion312. The tines 372 of the first and second plate members 306, 308 mayassist in holding the soft tissue end portions within the cradle portion324. Upon the physician being satisfied with the position of the severedend portions within the cradle portion 324, the physician may rotate theturn knob 426 to move the cartridge 322 and the various pushingcomponents distally toward the cradle portion 324. As depicted in FIG.37, the cartridge 322 is moved to a distal position adjacent the cradleportion 324. With the cartridge in this distal position, the repairdevice 300 is ready to be engaged and deployed.

With reference to FIGS. 36 and 37, the first and second anchors 302, 304are positioned within the cartridge (cartridge not shown) in apre-deployed state. The first and second anchors 302, 304 may beprecisely aligned and positioned relative to the first and second platemembers 306, 308 with the cartridge (not shown) being held within thechannel 444 defined in the cradle portion via the base alignment portion440 (FIG. 31), as previously discussed.

At this juncture, the trigger handle 450 may be actuated via a trigger472 of the trigger handle 450 to push the push button 462 at theproximal end of the push rod 454 (see FIG. 32A), to thereby, force thepush rod 454 and pusher block 456 through the cartridge 322 to deploythe first and second anchors 302, 304 from the cartridge 322. The legs332 of the first and second anchors 302, 304 will then be forced throughthe soft tissue, through notches 376 and openings 378 of the first andsecond plate members 306, 308 to then engage the anvil buckets 400 andbe directed, via the orientation and structural characteristics of theanvil buckets 400, to curl around structure of the plate members andback through openings 378 defined within the plate members and back intothe soft tissue, as depicted in FIGS. 38 and 38A. The physician may thenrotate the turn knob 426 to retract the empty cartridge 322 from thecradle portion 324. The physician may then remove the elongated handleassembly 420 from the deployed repair device 300 in the soft tissue.

With respect to FIGS. 38, 38A, and 39, simplistic views of the repairdevice 300 sandwiching the soft tissue 5 is depicted. In one embodiment,the repair device 300 provides structural characteristics thatfacilitate healthy repair of the soft tissue 5. As previously set forth,the repair device 300 defines the first portion 314 that may elongate(so as to be moveable to a longer state), the first portion 314including the first anchor 302 and first plate member 306. Similarly,the repair device 300 defines the second portion 316 that may elongate,the second portion 316 including the second anchor 304 coupled to thesecond plate member 306. Further, as previously set forth, the repairdevice 300 also defines an intermediate portion 318 that substantiallyresists elongation, the intermediate portion 318 including the anchorcoupling portion 310 and the plate coupling portion 312. In this manner,the first and second portions 314, 316 of the repair device 300facilitate healthy exercise of the soft tissue 5 (to prevent atrophy ofthe tendon) as the severed first and second ends 11, 13 of the softtissue 5 maintain contact with each other with the intermediate portion318 of the repair device 300 substantially resisting elongation.

In another embodiment, the anchor coupling portion 310 and the platecoupling portion 312 may be configured to break or fail under a highforce, imposed by way of extreme activities or accident. For example,the repair device 300 may satisfactorily hold onto soft tissue undernormal forces applied to the soft tissue 5. However, in the event apatient is in an accident or undergoes an activity in which a largeforce is applied to the treated soft tissue 5 with the repair device300, the anchor coupling portion 310 and the plate coupling portion 312may be designed to release or decouple should the force on the softtissue 5 reach a pre-determined threshold force, the predeterminedthreshold force being less than a holding force of the repair device 300to the soft tissue 5. As such, upon reaching a pre-determined thresholdforce, the anchor and plate coupling portions 310, 312 may include amechanical link 474 designed to release or decouple the anchor and platecoupling portions 310, 312 between the respective first and secondanchors 302, 304 and first and second plate members 306, 308 so as toprevent the anchors 332 from ripping through the end portions of thesoft tissue 5. Should such decoupling occur, it is much easier for aphysician to re-couple the first and second portions 314, 316 of therepair device 300, rather than lose valuable soft tissue length tore-attach the end portions of the soft tissue. In one embodiment, themechanical link 474 may be the one or more filaments 368 of the anchorand plate coupling portions 310, 312. In another embodiment, themechanical link 474 may be an additional structure, such as a ring,crimp, or latch to which the one or more filaments attach to, or someother suitable structure that is designed to de-couple upon reaching apre-determined force. The mechanical link may be integral to and extendfrom one or both of the first and second anchors 302, 304 and/or thefirst and second plate members 306, 310.

Now with reference to FIGS. 40 and 41, another embodiment of first andsecond anchors 502, 504 and first and second plate members 506, 508 of arepair device 500 is provided. In concept, this embodiment may besimilar to the embodiment depicted in FIGS. 22 and 23, except theanchors and plate members may exhibit other unique structuralcharacteristics. With respect to FIG. 40, the first and second anchors502, 504 may be formed from sheet material such that each of the firstand second anchors 502, 504 may be unitary or a monolithically formedstructure. The first and second anchors 502, 504 may each include a baseportion 510 with multiple legs 512 extending from the base portion 510.The base portion 510 of each of the first and second anchors 502, 504may extend generally within a plane. Further, the base portion 510 ofthe first and second anchors 502, 504 may define an axis 513 such thatthe first and second anchors 502, 504 may be aligned longitudinallyrelative to each other along the axis 513. Similar to that depicted inprevious embodiments, subsequent to the first and second anchors 502,504 being cut from sheet material, the legs 512 may be bent at theirrespective base to a bent position as depicted. The base portion 510 ofeach of the first and second anchors 502, 504 may include a firstelongate portion 514 and a second elongate portion 516. The first andsecond elongate portions 514, 516 may be interconnected by a singlelateral extending portion 518 therebetween. Each of the first and secondelongate portions 514, 516 may include at least two legs extendingtherefrom such that each anchor may include at least four legs. Inanother embodiment, the first and second anchors may include six legs ormore. As in previous embodiments, each of the legs 512 may extendgenerally or substantially perpendicular relative to a plane defined bythe base portion 510 of each of the first and second anchors 502, 504.

The first and second anchors 502, 504 may be coupled together with oneor more anchor filaments 520, for example, wrapped between the lateralextending portions 518 of each base portion 510 of the first and secondanchors 502, 504. As in previous embodiments, the one or more anchorfilaments 520 may take multiple wrappings or windings to ensure thefirst and second anchors 502, 504 are appropriately coupled together.The portion along the length of the repair device 500 described as theone or more anchor filaments may be referenced as a mid portion 522 ofthe repair device 500. Further, the first and second elongate portions514, 516 of each of the first and second anchors 502, 504 may eachinclude a curved portion 524 along a length thereof. The curved portion524 may be sized and configured to facilitate the base portion 510 orthe respective first and second elongate portions 514, 516 to stretch orelongate relative to the mid portion 522 so as to move toward a linearconfiguration upon a force being applied thereto. In this manner,similar to previous embodiments, this embodiment may provide for firstand second end portions 526, 528 of the repair device 500 to elongatealong a length of the repair device 500 with the mid portion 522 of therepair device 500 sized and configured to minimize elongation of therepair device 500.

Furthermore, each of the first and second anchors 502, 504 may definemultiple pairs of legs 512, such as, inner legs 530, middle legs 532 andouter legs 534, the inner legs 530 being closer to the repair site andthe outer legs 534 being furthest from the repair site and the middlelegs 532 being between the inner legs 530 and the outer legs 534. Eachof the inner legs 530, middle legs 532 and outer legs 534 having one legextending from one of the first and second elongate portions 514, 516 ofthe first and second anchors 502, 504. The lateral extending portion 518that connects the first and second elongate portions 514, 516 may extendbetween the inner legs 530 and the middle legs 532 such that the lateralextending portion 518 may be set back from the inner legs 530. Further,each of the legs 512 extending from the first elongate portion 514 maybe described as first legs and each of the legs 512 extending from thesecond elongate portion may be described as second legs. In oneembodiment, the first legs may be aligned and the second legs may bealigned such that the tips 536 or free ends of the first legs aresubstantially aligned and the tips 536 or free ends of the second legsare substantially aligned.

In another embodiment, the tips 536 or free ends of the first legs maybe laterally spaced relative to the axis 513 at different distancesrelative to each other. The tips or free ends of the second legs mayalso be laterally spaced relative to the axis 513 at different distancesrelative to each other. In another embodiment, spacing between each ofthe inner legs 530, middle legs 532, and outer legs 534 may be similar,but may be offset relative to each other. In still another embodiment,spacing between the inner legs 530 and outer legs 534 may be similar andthe middle legs 532 may be narrower or wider than the inner legs 530 andouter legs 534. Such varying spacing or offset leg pairs may result inthe tips of the first legs and the second legs to enter the soft tissueat varying lateral positions relative to an axis of the soft tissue (notshown) to gather varying longitudinal tissue bundles, upon deploying andfixating the repair device 500 to the soft tissue, such as a tendon orligament. For example, FIG. 49 is an end view of one of the first andsecond anchor 502, 504, depicting the outer legs 534 having a firstspacing 538 and the middle legs 532 having a second spacing 540. In oneembodiment, the second spacing 540 may be wider than the first spacing538.

With reference to FIG. 41, the first and second plate members 506, 508of this embodiment may each include a main body 542 having a peripheryor peripheral sides extending to define opposite face surfaces or sidesof the main body 542. The opposing face surfaces of the main body 542 ofthe first and second plate members 506, 508 may be generally planar soas to exhibit flat members. The first and second plate members 506, 508may be referenced as a substrate or backing member to the repair device500. The periphery of the main body 542 may define inner and outerperipheral portions that may extend to exhibit a generally u-shapedconfiguration such that portions of the u-shaped configuration mayexhibit radial portions or curved portions 560. The first and secondplate members 506, 508 may each define a width 544 and a length 546.Further, the first and second plate members 506, 508 may include tines548 extending transverse relative to the planar main body 542 and sizedand configured to pierce and extend into tissue.

In one embodiment, the tines 548 of the first and second plate members506, 508 may be canted toward the repair site. In another embodiment,the tines 548 may be canted away from the repair site. In still anotherembodiment, the tines 548 may extend substantially perpendicularrelative to the plate members. But for the tines, the first and secondplate members 506, 508 may extend in a plane or be substantially flat.As in previous embodiments, the first and second plate members 506, 508may each be a monolithically formed structure with the tines 548 benttransverse relative to the main body 542. Further, the first and secondplate members 506, 508 may be cut from a sheet material and, as such,the cut sheet material may be flat and plate like and further, the firstand second plate members 506, 508 may exhibit a square or rectangularcross-section. The first and second plate members 506, 508 may be formedfrom, for example, a metallic material, such as stainless steel or anyother suitable medical grade material, and be cut from sheet material bylaser cutting or any other suitable cutting technique known by one ofordinary skill in the art.

Each of the first and second plate members 506, 508 may include firstand second elongated portions 550, 552 extending from a base end 554. Ateach base end 554 of the first and second plate members 506, 508, one ormore plate filaments 556 may be employed to couple the first platemember 506 to the second plate member 508. Further, the first and secondelongated portions 550, 552 may each define one or more apertures 558therein and/or one or more curved portions 560. The apertures 558 and/orthe curved portions 560 may be sized and configured to receive and becaptured by the legs 512 of the first and second anchors 502, 504,described in further detail herein and similar to that described inprevious embodiments. Further, the curved portions 560 may be sized soas to facilitate the first and second plate members 506, 508 to elongateor move to a more linear position so that the length of the first andsecond plate members 506, 508 elongates so as to become longer. In thismanner, similar to the first and second anchors 502, 504, upon a loadbeing placed upon the repair device 500, the first and second platemembers 506, 508 may elongate while a mid portion 562 defined by, forexample, the one or more plate filaments, resists elongation to maintaina substantially fixed position.

With respect to FIGS. 42 and 43, similar to embodiments described inFIG. 27, the before-described first and second plate members 506, 508(FIG. 41) may be positioned in a cradle portion 564 of a cradle 566 of adelivery device (not shown). The cradle portion 564 of this embodimentmay include a bed surface 568 with anvil buckets 570 defined in the bedsurface 568. The bed surface 568 may be defined by a peripheral wall 572sized and configured with contours shaped to receive the first andsecond plate members 506, 508. The bed surface 568 may be separated witha channel or window 574 defined in the cradle portion 564 so as toseparate the bed surface 568 and cradle portion 564 into separate partsor two portions, for example, a first bed surface 576 and a second bedsurface 578. The window 574 may provide two functions, such as,increasing the viewability of the repair site as well as providing arelief for the ends of the soft tissue being fixated so that anypotential trumpeting of the tissue ends maintain a localized position.

Further, the bed surface 568 may include pins 580 separately formed andset within apertures defined in the bed surface 568. The apertures maybe machined or pre-formed so that the pins 580 may be inserted throughthe underside of the cradle portion 564 and positioned within theapertures so as to extend from the bed surface 568 to about the heightof the peripheral wall 572. The pins 580 may include a crimp or taper orbevel so that upon positioning within their corresponding aperture, thepins 580 are maintained with an interference fit. The cradle portion 564may also define multiple holes 582 extending therethrough. Such holes582 may be used to facilitate temporarily holding (via one or morefilaments (not shown)) the first and second plate members 506, 508against the bed surface 568 of the cradle portion 564.

The first and second bed surfaces 576, 578 may each include multipleanvil buckets 570. In one embodiment, the anvil buckets 570 may beseparated so as to define pairs of anvil buckets 570. For example, eachof the first and second bed surfaces 576, 578 may include pairs of anvilbuckets 570 defined as inner anvil buckets 584, middle anvil buckets586, and outer anvil buckets 588. Each pair of anvil buckets 570relative to one of the first and second bed surfaces 576, 578 may beunique relative to any other anvil bucket pair. In another embodiment,the anvil bucket pairs may be similar or substantially the same as otheranvil bucket pairs defined in the first and second bed surfaces. Thesimilarity or differences may be dependent upon a configuration of thefirst and second anchors 502, 504 (FIG. 40) such that each anvil bucket570 may be sized and configured to correspond with one of the legs 512of the first and second anchors 502, 504.

Now with reference to FIG. 44, the first and second plate members 506,508 may be positioned on the cradle portion 564 and within the bedsurface 568. The pins 580 and the contours of the peripheral wall 572defining the bed surface 568 may assist in aligning and holding thefirst and second plate members 506, 508 at an appropriate positionwithin the cradle portion 564. Further, the one or more apertures 558and/or curved portions 560 of each of the first and second plate members506, 508 may be positioned over a mid-portion of the anvil buckets 570defined in the bed surface 568. The base end 554 of each of the firstand second plate members 506, 508 may at least partially extend beyondthe bed surface 568 so as to hang over the window 574 of the cradleportion 564. Once the first and second plate members 506, 508 arepositioned within the respective first and second bed surfaces 576, 578,the one or more wires or filaments (not shown) may extend through theholes 582 and over the first and second plate members 506, 508 to ensurethe plate members do not lift from the cradle portion 564.

With respect to FIGS. 43 and 45, the first and second anchors 502, 504and the first and second plate members 506, 508 are depicted in aposition just prior to the legs of the anchors engaging with the anvilbuckets 570. As depicted, each anvil bucket 570 may be positioned in thecradle portion 564 to correspond with one of the legs 512 of the firstand second anchors 502, 504. Upon positioning the first and second platemembers 506, 508 in the cradle portion 564 as previously described,portions of the first and second plate members 506, 508 extend over theanvil buckets 570 so as to be positioned and to correspond with the legs512 of the first and second anchors 502, 504. Similar to that describedin earlier embodiments, the anvil buckets 570 may be sized andconfigured to receive the legs 512 of the first and second anchors 502,504 to facilitate the legs 512 to bend and wrap around portions of thefirst and second plate members 506, 508 that extend over the anvilbuckets 570.

Such anvil buckets 570 may include a receiving portion 590 and an exitportion 592 that manipulates the legs 512 in a pre-determined directionand orientation. Further, each of the anvil buckets 570 may include anengaging side wall 594 that extends between the receiving portion 590and the exit portion 592 of the anvil buckets 570 so as to manipulatethe legs 512 in such pre-determined direction and orientation. Theengaging side wall 594 may extend transverse relative to the bed surface568 at, for example, an angle extending at about 75-105 degrees or80-100 degrees. In regard to the inner and outer anvil buckets 584, 588,the engaging side wall 594 may be the inner or adjacent side walls ofthe anvil bucket pairs. In regard to the middle anvil buckets 586, theengaging side wall 594 may be the outer side walls relative to the anvilbucket pairs. The receiving portion 590 of the anvil buckets 570 mayinclude a descending, sloped floor 596 and the exit portion 592 of theanvil buckets 570 may include an ascending, sloped floor 598 so that thelegs 512 may pierce back into tissue. Further, the receiving portion 590may define a larger surface area than the exit portion 592. In thismanner, the anvil buckets 570 may be sized and configured to manipulatethe curling or wrapping of the legs 512 of the first and second anchors502, 504 around portions of the respective first and second platemembers 506, 508 in a substantially consistent fashion.

With respect to FIG. 46, another embodiment of a cradle portion 561 of acradle 563 is depicted. In this embodiment, instead of the beforedescribed pins 580 (FIG. 42) extending from the bed surface, one or moreislands 565 or one or more protrusions extending from a first bedsurface 567 and a second bed surface 569 of the cradle portion 561 areprovided, this embodiment of the cradle 563 being similar in all otheraspects previously described for the cradle/cradle portion. As inprevious embodiments, the cradle portion 561 may be separated between afirst part 571 and a second part 573, each of the first and second parts571, 573 having at least one of the islands 565 defined in the first bedsurface 567 and the second bed surface 569. In one embodiment, a singleisland 565 may extend as a protrusion or raised structure from each ofthe first bed surface 567 and the second bed surface 569. In anotherembodiment, each island 565 may extend with an S-configuration orsimilar configuration, such as a L-configuration or the like. Suchislands 565 may be positioned and extend adjacent to a first lateralside 575 of the bed surface to adjacent a second lateral side 577 of thebed surface and extend alongside multiple ones of anvil buckets 579defined in each of the first and second bed surfaces 567, 569, aspreviously described. The first and second lateral sides 575, 575 of thebed surface may be defined by a peripheral wall 581 raised above each ofthe first and second bed surfaces 567, 569. The islands 565 may extendwith a height similar to the peripheral wall 581 or may extend higherthan such peripheral wall 581. As depicted in FIGS. 46 and 47, similarto the before described pins, the islands 565, in combination with theperipheral wall 581, may stabilize and prevent movement, laterally andlongitudinally, of the first plate member 506 and the second platemember 508 within the respective first and second bed surfaces 567, 569of the cradle portion 561. In this manner, the islands 565 may bepositioned within the first and second bed surfaces 567, 569 to directlycontact inner sides of the first and second plate members 506, 508positioned in the cradle portion 561. The islands may be formedintegrally with the cradle portion 561 or may be formed as separatecomponents and attached similarly as the pins such that the islands 565may include extensions/pins extending from an underside of the islandsto couple to holes bored therein. As such, the islands 565 may be formedwith the cradle 563 employing machining or molding techniques as knownto one of ordinary skill in the art.

With respect to FIG. 48, an enlarged profile view of some of the legs512 of one of the first and second anchors 502, 504 is provided. Withreference to FIGS. 48 and 49, the legs 512 may each include a length602, a width 604, and a thickness 606, the length 602 being longer thaneach of the width 604 and the thickness 606 and the thickness 606 beinga substantially constant thickness. The width 604 may include a varyingdimension along the length 602 of a given leg. Each leg may include abase portion 608, a first tapered portion 610, a second tapered portion612, and a third tapered portion 614 such that the width 604 may varyalong the length 602. The base portion 608 may include a substantiallyconstant width 604. The first tapered portion 610 may include a firsttapering width between the base portion 608 and the second taperedportion 612. The second tapered portion 612 may include a secondtapering width between the first tapered portion 610 and the thirdtapered portion 614. The second tapered portion 612 may include a thirdtapering width extending between the second tapered portion 612 and afree end or the tip 536 of the leg 512. The second tapered portion 612may be longer than the first and third tapered portions 610, 614. Thefirst tapered portion 610 may be longer than the third tapered portion614. The free end or tip 536 of a give leg 512 may include a radius orrounded surface end.

Further, the width 604 of each leg 512 may be defined by a first surface616 and a second surface 618. In one embodiment, the first surface 616may be substantially planar or continuous along the base portion 608,the first tapered portion 610, and the second tapered portion 612. Thefirst surface 616 along the third tapered portion 614 may be angled soas to provide an engaging surface 624. This engaging surface 624, alongwith the tip 536 may be sized and configured to engage the anvil buckets570 (FIG. 43). The second surface 618 may include one or more slopingangles to provide a varying width or taper along the length 602 of eachleg 512. For example, in one embodiment, the second surface 618 of thefirst tapered portion 610 may include a slope at a first angle 620 andthe second surface 618 of the second tapered portion 612 and the thirdtapered portion 614 may include a slope at a second angle 622. Thesecond surface 618 along the second tapered portion 612 and the thirdtapered portion 614 may be sloped and extend continuously or planar. Inthis manner, the second surface 618 of the legs 512 may be sloped fromthe base portion 608 and along the first, second, and third taperedportions 610, 612, 614 so that the legs 512 taper from the base portion608 to the tip 536. With this arrangement, upon the legs 512 of thefirst and second anchors 502, 504 being forced through the tissue andthen against the anvil buckets (now shown), such varying width of thelegs 512 may be sized so as to manipulate the legs to consistentlyextend back into the tissue in a curling manner without buckling orbending inappropriately. In another embodiment, the first surface 616and the second surface 618 may include one or more slopes to provide oneor more tapers along the length of the legs 512. In still anotherembodiment, each leg 512 may include substantially similar dimensions ofits respective length 602, width 604, and thickness 606, but may beoriented about the longitudinal axis of a given leg so that the engagingsurface 624 of each leg may be oriented 90 degrees to 180 degreesrelative to the engaging surface 624 of adjacent legs or other legs of agiven anchor. In this manner, such engaging surface 624 of the legs 512may be oriented and positioned consistent with and relative toorientations of corresponding anvil buckets 570 defined in the bedsurface of the cradle portion 564 (see FIG. 45).

In one embodiment, the second angle 622 defined by the slope of thesecond surface 618 along the second tapered portion 612 and the thirdtapered portion 614 may be in the range between about 1 degree and 10degrees and preferably between about 1 degree and 5 degrees. Forexample, the second surface 618 may slope with the second angle 622being about 2.6 degrees.

In another embodiment, the first surface 616 and the second surface 618may each slope so as to taper at an angle of about 1.3 degrees.Dependent upon the tissue to which the anchors are to be fixated, thelength 602 of the legs 512 may vary. In the case of fixating the anchorsto a flexor tendon or the like, the length 602 of the legs 512 may beabout 0.2 inches or between about 0.15 and 0.25 inches. The length ofthe second tapered portion 612 may be about 0.13 inches or between about0.10 to 0.2 inches. The width 604 of the second tapered portion 612 maytaper from about 0.012 to 0.006 inches so as to have a 2:1 ratio inwidth change along the length of the second tapered portion 612. Thiswidth change ratio for the second tapered portion 612 may be in therange of about 1.5:1 ratio to a 5:1 ratio dependent upon the length ofthe legs 512, which also may be dependent upon the tissuethickness/diameter. Such dimensions of the second tapered portion 612 ofthe legs 512 facilitate the legs to curl appropriately and minimize theprobability of buckling in the legs.

Now with reference to FIGS. 50, 51, and 52, one embodiment of a deliverydevice 630 will now be described. The delivery device 630 of thisembodiment is similar to earlier embodiments of the delivery devicedepicted in FIGS. 32 and 37. In this embodiment, the delivery device 630may include a trigger gun 632, an adapter assembly 634, and anapplicator assembly 636. The trigger gun 632 may include a trigger 638such that the trigger gun 632 provides a force for delivering the firstand second anchors 502, 504, as previously described. On example of atrigger gun 632 configured to deliver a force by compressing the trigger638 is described in U.S. Pat. No. 5,344,061, the disclosure of which ishereby incorporated herein by reference in its entirety.

The adapter assembly 634 may be coupled between the trigger gun 632 andthe applicator assembly 636. The components of the adapter assembly 634may include a stroke regulator 640, a push rod 642, a return spring 644,an adapter tube 646, and a slide lock 648. The stroke regulator 640 mayalso be referenced as a force regulator or a trigger regulator. Thestroke regulator 640 may be configured to ensure that the trigger 638completes a full trigger stroke before returning to its originalposition and to ensure that the first and second anchors 502, 504 arefully deployed. The stroke regulator 640 may be, for example, anelastomer material sized to compress under a predetermined force tocomplete or allow for a full trigger stroke such that, upon making thefull trigger stroke, such may be indicated with, for example, a click oranother indicator, such as the trigger handle returning to its originalposition. The click or returned trigger position being an indicator formaking the full trigger stroke and fully clamping the repair device tosoft tissue. The push rod 642 may be coupled to the stroke regulator 640and may be positioned within the adapter tube 646 with the return spring644 extending around a portion of the push rod 642. The slide lock 648may be positioned around a distal portion of the adapter tube 646 suchthat the distal end of the adapter tube 646 interlocks with a proximalend of the adapter assembly 634.

The applicator assembly 636 may include many of the same components ofthe applicator assembly or elongated assembly of previous embodiments.For example, the applicator assembly 636 may include an applicatorhandle 650 that houses a worm drive 652, a thumb wheel 654, and theapplicator push rod 656. The applicator handle 650 may include a distalhousing 658 that houses a cartridge 660 and a pusher member 662, thepusher member 662 abutting the end of the applicator push rod 656.Further, the applicator assembly 636 includes the cradle 566 with aproximal portion fixed to an internal surface of the distal housing 658.The cartridge 660 may include an internal surface shaped to correspondwith a top periphery profile of the first and second anchors 502, 504 sothat the first and second anchors may be positioned within a distalportion of the cartridge 660 with the pusher member 662 positionedwithin the cartridge 660 directly adjacent and proximal the first andsecond anchors 502, 504. Further, a worm drive cover 664 may bepositioned proximal the distal housing 658 to cover a portion of theworm drive 652.

Upon rotating the thumb wheel 654, all components of the delivery device630 are linearly moveable, except for the applicator handle 650 and thecradle 566. As indicated by rotation arrow 667, the thumb wheel 654rotates, but also remains linearly stationary. The thumb wheel 654 maybe tubular and may rotate about an axis 668 of the applicator assembly636. The thumb wheel 654 may include threads 670 or a protrusion alongan internal surface thereof which corresponds with the threads 670 alongan external surface of the worm drive 652 to facilitate linear movementof the cartridge 660 (and other components previously set forth) alongthe axis 668 of the applicator assembly 636. Further, the thumb wheel654 may include an internal surface sized to interact with a flexiblewire (not shown) extending from, for example, the worm drive 652 sizedand configured to limit the force of a distal end of the cartridge 660pressed against the soft tissue. In other words, the applicator assembly636 may include a force limiter (not shown) or torque limiter that, uponrotating the thumb wheel to linearly move the applicator assembly 636toward the cradle portion and upon the cartridge 660 making contact withthe soft tissue in the cradle portion, the force limiter may facilitateobtaining a consistent pressure or force applied to the soft tissueprior to deploying the anchors from the cartridge 660.

With respect to FIG. 51A, additional detail will be described relativeto the cradle 566, cartridge 660, and pusher member 662. In oneembodiment, the cartridge 660 may include cartridge coupling portions661 extending downward from opposing sides thereof. Such cartridgecoupling portions 661 may be in the form of a C-arm or the like that maybe sized and configured to wrap around and couple to opposing sides of aplatform 663 of the cradle 566. The platform 663 may include first andsecond rails 665, 667 on opposing sides of the platform 663 sized andconfigured to receive the corresponding cartridge coupling portions 661.Such cartridge coupling portions 661 may be slidably coupled to theplatform 663 so as to be linearly movable over and relative to thecradle 566.

Further, similar to previously described embodiments, the cartridge 660may include a hollow portion 669 sized and configured to receive andhold the first and second anchors 502, 504. Such hollow portion 669 mayinclude various grooves 671 and channels so as to correspond with a topprofile of the first and second anchors 502, 504. The grooves 671 andchannels may be defined by an inside wall surface of the cartridge 660.For example, the first and second anchors 502, 504 may be positionedwithin the hollow portion 669 such that the legs 512 of the first andsecond anchors 502, 504 may be slightly constrained against the wallsurface defining the grooves 671 and channels within the hollow portion669 of the cartridge 660 so that the first and second anchors 502, 504may be effectively maintained within the cartridge 660.

The pusher member 662 may be sized and configured to be positionedwithin the hollow portion 669 of the cartridge 660. The pusher member662 may include a distal end profile 673 and distal portion 675 sizedand configured to be pushed through the hollow portion 669 of thecartridge 660, the distal end profile 673 and distal portion 675 havingcontours that correspond with the various grooves 671 and channelsdefined in the wall surface of the hollow portion 669 of the cartridge660. Upon positioning the first and second anchors 502, 504 within thecartridge 660, the distal end profile 673 may be sized to push the firstand second anchors 502, 504 from the cartridge 660, similar to thatdescribed in previous embodiments. With this arrangement, the first andsecond anchors 502, 504 can be temporarily housed within the cartridge660 and effectively deployed from the cartridge 660 with the pushermember 662. As previously set forth, the cradle 566 may be formed of ametallic material and the cartridge 660 and pusher member 662 may beformed of a polymeric material, formed by employing molding and/ormachining techniques as known to one of ordinary skill in the art.

Now with reference to FIGS. 52, 53A-53C, a method of deploying the firstand second anchors 502, 504 with the delivery device 630 will now bedescribed. With respect to FIGS. 52, 53A, and 53B, the cradle portion564 of the applicator assembly 636 having the first and second platemembers 506, 508 positioned in the cradle portion 564 may be positionedadjacent a tissue repair site 501. The physician may then position softtissue 503 needing repair, such as a severed tendon or ligament, withinthe cradle portion 564 with abutting ends 505 of the soft tissue 503positioned adjacently above and between the base ends 554 of the firstand second plate members 506, 508. Upon the soft tissue 503 beingappropriately positioned within the cradle portion 564 over the firstand second plate members 506, 508, the physician may move the cartridge660 with the first and second anchors 502, 504 linearly, as shown byarrows 672, from a first position to a second position by rotating thethumb wheel 654. Such positions may also be referenced as a cartridgefirst position and a cartridge second position or an anchor firstposition and an anchor second position.

As shown in FIGS. 52 and 53C, the cartridge 660 is moved to the secondposition such that the exposed tips 536 (see FIG. 53A) of the first andsecond anchors 502, 504 are against end portions of the soft tissue 503.At this juncture, the physician may activate a deployment mechanism bypulling or compressing the trigger 638 of the trigger gun 632 to pushthe first and second anchors 502, 504 from the cartridge 660 and intothe soft tissue 503. Upon compressing the trigger 638, a force may beplaced along the axis 668 of the applicator assembly 634 from the pushrod 642, to the applicator push rod 656 to the pusher member 662. Thepusher member 662 forces the first and second anchors 502, 504 from thecartridge 660, through the soft tissue 503, and directly into the anvilbuckets 570 (FIG. 43) with the engaging surface 624 of the legs 512engaging the anvil buckets 570 to force and manipulate the legs 512 ofthe first and second anchor 502, 504 to move in a curling manner to wraparound portions of the first and second plate members 506, 508 and backinto an underside of the soft tissue 503, as depicted in FIG. 54B.

With reference to FIGS. 54A and 54B, a top view and a bottom view of thedeployed repair device 500 fixated to the soft tissue 503 of a softtissue repair site is provided.

Upon the first and second anchors 502, 504 being deployed from thecartridge 660 (FIG. 53C), the aims 512 extend through the apertures 558of the first and second plate members 506, 508 to curl around portionsof the first and second plate members 506, 508. Similarly, some of thelegs 512 may extend and curl around the curved portions 560 of first andsecond plate members 506, 508. As depicted, the one or more anchorfilaments 520 extend over the tissue repair site 501 and couple thefirst anchor 502 to the second anchor 504. Similarly, the one or moreplate filaments 556 extend over the opposite side of the tissue repairsite 501 and couple the first plate member 506 to the second platemember 508. As previously indicated, such filaments may resistelongation of the repair device 500 over a mid portion thereof. Further,depending upon the soft tissue 503 being repaired, such as a flexortendon, such filaments facilitate the repair device 500 to move over aradius.

With reference to FIGS. 55A and 55B, a top view and a bottom view,respectively, of another embodiment of one or more repair devices 680for fixating soft tissue 681, at a soft tissue repair site, to bone 683with a bone anchor 684. The one or more repair devices 680 being similarto a portion of the previously described repair device. In thisembodiment, such one or more repair devices 680 may employ, for example,a first anchor 684 coupled to a first plate member 686 such that legs688 of the first anchor 684 extend through the soft tissue 681 and thelegs 688 curl around portions of the first plate member 686, similar toprevious described embodiments. Upon fixating the one or more repairdevices 680 to the soft tissue 681, the one or more repair devices 680may be coupled to the bone anchor 682. For example, an anchor filament690 and a plate filament 692 extending from the respective first anchor684 and the first plate member 686 may be coupled to the bone anchor682. Such may be employed by extending a bone anchor filament 694through the anchor filament 690 and the plate filament 692 and theninserting and fixating the bone anchor 682 to bone 683. In this manner,one or more first anchors 684 may be coupled to one or more first platemembers 686 to fixate soft tissue 681 to bone 683. In anotherembodiment, the bone anchor filament 694 may be coupled directly to oneor both of the first anchors 684 as well as the bone anchor filament 694being coupled to one or both of the first plate members 686, instead ofemploying the anchor filament 690 and plate filament 692.

The components of the delivery device 630 may be formed and made withmedical grade metallic materials, such as stainless steel, titanium,Nitinol, and/or alloys thereof or any other suitable metallic materialor polymeric materials, such as liquid crystal polymers or acrylonitrilebutadiene styrene (“ABS”) or any other suitable polymeric materialsknown to one of ordinary skill in the art. Such device components may beformed by employing molding and/or machining techniques, or any othersuitable techniques and processes known to one of ordinary skill in theart. Further, the first and second anchors 502, 504 and first and secondplate members 506, 508, as set forth herein, may be laser cut frommedical grade sheet material, such as stainless steel, titanium,Nitinol, and/or alloys thereof or made from a bioresorbable materialsuch as zinc, polylactic-co-glycolic acid (“PLGA”) or any other suitablebioresorbable material described herein or known by one of ordinaryskill in the art.

Now with reference to FIGS. 56-57, another embodiment of a repair device700 that may be employed for fixating severed or ruptured soft tissue orfor coupling soft tissue to bone, as depicted and described above, isprovided. This embodiment of the repair device 700 is similar to theembodiment described and depicted relative to FIGS. 40 and 41, exceptthis embodiment may include some minor modifications. For example, inthis embodiment of the repair device, best depicted in FIG. 57, elongateportions 718 of first and second anchors 702, 704 may extend with lessof a curve than that depicted in FIG. 40 and described as the curvedportions 524. By straightening or forming the elongate portions 718 morelinear than curved, the elongate portions 718 of this embodiment, uponbeing fixated to soft tissue, may be sized and configured to minimizequilting of the repair device 700 relative to the soft tissue so as toenhance gliding of the repair device within, for example, a tendonsheath. Further, in this embodiment, the elongate portions 718 mayminimize any strain modulation in the first and second anchors 702, 704.

With respect to FIGS. 56-57, as set forth, the repair device 700 of thisembodiment is similar to the previous embodiment (FIGS. 40-41) in mostevery structural respect and therefore that which is described relativeto the previous embodiment is applicable to this embodiment. Asdepicted, the repair device 700 of this embodiment is shown in adeployed state or secured, coupled state. The repair device 700 mayinclude the first anchor 702 and the second anchor 704 alignedlongitudinally relative to each other and coupled together in a spacedmanner with a first flexible member 706 or anchor filaments. Further,the repair device 700 may include a first plate 708 and a second plate710 aligned longitudinally relative to each other and coupled togetherin a spaced manner with a second flexible member 712 or plate filaments.As depicted in FIG. 56, end portions 714 of legs 716 of the first andsecond anchors 702, 704 may be moved to bent, curled or wrappedpositions upon being forced against the anvil buckets 570 of a cradleportion 564 (FIG. 45). With this arrangement, the end portions 714 ofthe legs 716 of each of the first and second anchors 702, 704 may bemoved from a first position (similar to that depicted in FIG. 45) to asecond position, as depicted in FIG. 57, such that end portions 714 ofthe legs 716 may be manipulated to bend or wrap around portions of thefirst and second plate members 708, 710 via the before discussed anvilbuckets 570.

In one embodiment, the repair device 700 may include a first portion 720and a second portion 722, the first portion 720 and the second portion722 coupled with the first flexible member 706 and the second flexiblemember 712. The first portion 720 may include the first anchor 702 andthe first plate 708, the first anchor 702 sized to couple to the firstplate 708 via the legs 716 of the first anchor 702. The second portion722 may include the second anchor 704 and the second plate 710, thesecond anchor 704 sized to couple to the second plate 710 via the legs716 of the second anchor 704. In another embodiment, the first portion720 or the second portion 722 of the repair device 700 may be employedto be fixated to soft tissue with a flexible member coupled to, forexample, a bone anchor, similar to that depicted in FIGS. 55A and 55B.Such first portion 720 and/or second portion 722 may be appropriatelysized relative to the soft tissue the repair device 700 is beingemployed with for fixating to soft tissue.

In another embodiment, the first and second anchors 702, 704 may each beformed from a flat structure, such as a sheet material, as a singlemonolithic structure. Once formed from the sheet material, such as bylaser cutting or stamping, or any other suitable cutting method,portions of the first and second anchors 702, 704 may be bent toward asingle side of the flat structure to form the legs 716. In oneembodiment, each of the first and second anchors 702, 704 may includesix legs or more. In another embodiment, each of the first and secondanchors 702, 704 may include at least three legs, or at least four legs,or at least five legs. The number of legs 716 for a given anchor maycorrespond with portions of the first and second plates 708, 710, suchas apertures 724 and/or undulations 726 defined in the structure of thefirst and second plates 708, 710. In another embodiment, the first andsecond anchors 702, 704 may include a flat structure or base portionthat may extend in a generally U-shaped configuration with the legs 716extending away from the U-shaped configuration in a generally commondirection and away from a single side of the flat structure. In anotherembodiment, the first anchor 702 and the second anchor 704 may eachinclude two legs on opposite ends thereof with two legs extending from amiddle portion thereof to define six legs for each of the first andsecond anchors 702, 704. In another embodiment, the bottom end of theU-shaped configuration of the first and second anchors 702, 704 may faceeach other such that a bottom portion of the U-shaped configuration ofthe first and second anchors may be employed to wrap the first flexiblemember 706 to couple the first anchor 702 to the second anchor 704.

In another embodiment, the first and second plates 708, 710 may eachdefine one or more apertures 724 or at least one aperture. In anotherembodiment, the first and second plates 708, 710 may define amulti-cellular structure. In another embodiment, the first and secondplates 708, 710 may each include a single monolithic structure, formedfrom a sheet material. Once cut from the sheet material via, forexample, laser cutting, stamping, or any other suitable method, the cutplate members may include tines 728 that may then be formed to extend ina generally common direction, such as, upward or from a single side ofthe plate member. Such tines 728 may include an orientation, such asupward and toward the side or end that the second flexible member 712couples to the first and second plates 708, 710. In another embodiment,the first and second plates 708, 710 may extend with undulations 726along a periphery 730 of the plate members. In another embodiment,apertures 724 defined in the structure may be formed internal theperiphery 730 with the undulations 726. Such apertures 724 and/orundulations 726 defining the structure of the first and second plates708, 710 may be sized and configured to receive the end portions 714 ofthe legs 716 of the first and second anchors 702, 704 to wrap or curlaround portions of the first and second plates 708, 710.

As set forth in previous embodiments, the first and second flexiblemembers 706, 712 may be formed of one or more filaments wrapped aroundinner portions of the first and second anchors 702, 704 and the firstand second plates 708, 710, respectively. The one or more filaments maybe any suitable filament, such as a biocompatible polymeric filament orthe like, for example, ultra-high molecular weight polyethylene.

With respect to FIGS. 56 and 58, as set forth, the repair device 700 maybe coupled together and fixated to soft tissue 701. Upon the repairdevice 700 being clamped or fixated to the soft tissue 701, exposedportions of the repair device 700 may be low profile relative to a firstside 703 and second side 705 of the soft tissue 701. Further, the repairdevice 700 may create a recess 707 or depressed portion in the softtissue 701 such that exposed portions of the repair device 700 provideminimal structure extending beyond a height 709 or diameter of the softtissue 701. As depicted, the repair device 700 may be secured andmaintained to the soft tissue 701 with the legs 716 and tines 728 atmultiple locations. For example, at the first side 703 of the softtissue 701, the legs 716 of the first and second anchors 702, 704 extendinto the first side 703 and through the soft tissue 701 and back intothe second side 705 of the soft tissue 701. At the second side 705 ofthe soft tissue, tines 728 extending from the first and second plates708, 710 may extend into the soft tissue 701 as well as end portions 714of the legs 716 extending into the soft tissue 701.

With respect to FIGS. 56, 57 and 58, in one embodiment, at the firstside 703 of the soft tissue 701, the legs 716 of the first and secondanchors 702, 704 extend into the soft tissue 701 such that adjacentpositions of entrance into the soft tissue 701 by the legs 716 are notlongitudinally aligned with each other. For example, middle legs mayextend from the first and second anchors 702, 704 a first distance 732from a longitudinal axis 736 of the first and second anchors 702, 704,and the legs 716 on opposite ends of the first and second anchors 702,704 may extend relative to the longitudinal axis 736 of the first andsecond anchors 702, 704 a second distance 734, the first distance 732being larger than the second distance 734. In another embodiment, thefirst distance may be smaller than the second distance. Similarly, inone embodiment, the adjacent positions of entrance into the soft tissue701 at the second side 705 of the soft tissue 701 of the end portions714 of the legs 716 relative to the tines 728 of the plates are notlongitudinally aligned. In other words, the end portions 714 of the legs716 may be positioned at different distances than the tines relative toa longitudinal axis of the plate members. In this manner, as a force isplaced upon the soft tissue with the repair device 700 fixated thereto,the longitudinally extending tissue fibers may be less apt tolongitudinally tear along a common longitudinal line where adjacent armsextend through the soft tissue 701.

Furthermore, by coupling the legs 716 of the first and second anchors702, 704 to wrap around portions of the first and second plates 708,710, a force that may be placed on the soft tissue may be maximizedwithout the repair device 700 being pulled out of the soft tissue 701.In other words, the soft tissue 701 may fail before the low profilerepair device 700 fails such that the repair device 700 may remainintact and coupled together.

Now with reference to FIGS. 59, 59A, and 59B, another embodiment of anapplicator assembly 740 with an integrated slip clutch element 742 orslip clutch arrangement is provided. The applicator assembly 740 of thisembodiment may include similar components as the applicator assembly 636described and depicted in FIGS. 50, 51, and 52. In this embodiment, theslip clutch element 742 integrated with the applicator assembly 740 maybe integrated into a thumb wheel 744 and a worm drive 746 of theapplicator assembly 740. As in previous embodiments, the worm drive 746may include threads 748 such that, upon rotating the thumb wheel 744,the worm drive 746 moves linearly to move a cartridge 750 toward a bedsurface 752 of a cradle portion 754. The thumb wheel 744, at least alonga longitudinal portion thereof, may include slots 756 or the likeextending longitudinally along the length and along an internal radialsurface 758 of the thumb wheel 744. The worm drive 746 may include afinger 760 or clutch element (or finger element) in the form, forexample, a wire or ring such that a portion of the finger 760 extendsinto one of the longitudinally extending slots 756 defined in the thumbwheel 744. The finger 760 may be fixed and embedded into the worm drive746. As the thumb wheel 744 is rotated to move the worm drive 746distally and, thus, move the cartridge 750 distally toward the cradleportion 754, the worm drive 746 also moves rotationally and linearlysuch that the finger 760 moves distally relative to the thumb wheel 744along one of the slots 756 defined in the internal radial surface 758 ofthe thumb wheel 744. Upon the cartridge 750 being moved distally againstthe soft tissue positioned in the cradle portion 754 and pressingagainst the soft tissue with a predetermined force, the finger 760extending in one slot may slip out of the one slot and move to anadjacent slot (and continue to move to adjacent slots) as the thumbwheel 744 is rotated, thereby, removing additional distal movement ofthe worm drive 746 and limiting any additional force of the cartridge750 against the soft tissue. In this manner, the slip clutch element 742(finger 760 cooperating with the internal geometry of the slot 756) maybe sized and configured with a predetermined stiffness to be a torquelimiter to facilitate consistent torque or clamping force of thecartridge 750 against the soft tissue. Further, the slip clutch element742 integrated in the applicator assembly 740 (or any one of thedelivery device systems set forth herein) may be sized and configured tofacilitate consistent deployment and coupling of any one of the repairdevice embodiments, such as repair device 700, to the soft tissue so asto better control the outcome of fixating the repair device 700 to softtissue.

In one embodiment, the finger 760 may be a wire, such as a linear wireor a wire with a radius, embedded in the worm drive 746. In anotherembodiment, the finger 760 may be a circular wire member or a ringstructure fixed to and embedded into the worm drive 746. In stillanother embodiment, the finger 760 may be positioned off-center relativeto an axis of the worm drive 746 (as depicted in FIG. 59B) so that thefinger 760 may slip out of a given slot 756 when rotating the thumbwheel 744 in one direction, but withstand slipping out of a given slot756 when rotating the thumb wheel 744 in the opposite direction. Inanother embodiment, the force applied to the soft tissue by a distal endof the cartridge 750 is a function of a bendability of the finger 760and the geometry of the internal slot 756. In another embodiment, thefinger 760 may be formed from a Nitinol material. In another embodiment,the finger 760 may be a flexible polymeric finger molded with the wormdrive 746 or embedded in the worm drive 746.

With reference to FIG. 60, another embodiment of a delivery device 770,in simplified form, is provided. The delivery device 770 may include anactuator member 772, a device delivery portion 774, and a firing member776. The actuator member 772 may include a body 777 and an actuatorportion 778, the body 777 sized to receive a portion of the actuatorportion 778 in a syringe like manner. The body 777 may include, forexample, a tube structure 780 with a finger holder 782 at a proximal endthereof. The finger holder 782 may include two ring-like structures fora physician to position two fingers therein. The actuator portion 778may include an elongate portion 784 extending through the tube structure780 with a coupling structure 786 at a distal end and a ring structure788 at a proximal end of the elongate portion 784. The tube structure780 may include indicia 789 on the tube structure 780 so as to indicateto a physician a thickness or size of the soft tissue being fixated toensure an appropriately sized repair device is fixated to the softtissue. The coupling structure 786 may be sized and configured to coupleto the device delivery portion 774.

The device delivery portion 774 may include a cradle 790 and a cartridge791, similar to the cradle and cartridge described in previousembodiments. The cradle 790 may include a proximal portion 792 and acradle portion 794, the proximal portion 792 including an upper side 795with a track (not shown) that may couple to a corresponding track alonga distal side portion 796 of the tube structure 780, as indicated bydotted line 781. The coupling structure 786 of the actuator member 772,as previously indicated, may be coupled to a proximal side 797 of thecartridge 791, as indicated by dotted line 783. The cradle 790 iscoupled to the tube structure 780 in a fixed manner. The cartridge 791may also be coupled to the coupling structure 786 in a fixed manner,however, the cartridge 791 may linearly slide relative to the cradle790, as discussed in previous embodiments. In this manner, linearmovement of the actuator portion 778 may linearly move the cartridge 791relative to the cradle 790 such that the cradle 790 and tube structure780 may remain fixed and stationary.

As set forth, the firing member 776 may be operatively coupled to theactuator member 772 and the device delivery portion 774, as indicated bydotted line 785. In one embodiment, the firing member 776 may beactivated with and include a manual trigger and handle such that thetrigger acts like a lever to move a pusher member, similar to previousembodiments. In another embodiment, the firing member 776 may activate apusher member hydraulically or pneumatically, or any other suitablestructure or means such that the firing member may be activated manuallywith a lever and translate the required force to a pusher member toeffectively eject anchors from the cartridge and deploy the repairdevice.

Once the actuator member 772 is coupled to the device delivery portion774, a physician may then position the severed soft tissue within thecradle portion 794, similar to that described in previous embodiments.Upon positioning the severed soft tissue within the cradle portion 794,the physician may then grasp the actuator member 772 by placing onesthumb in the proximal ring structure 788 and two fingers in the fingerholders 782. The physician may then readily move a distal end of thecartridge 791 toward a cradle portion 794 of the cradle 790 and snugover the soft tissue positioned in the cradle portion 794. If thephysician is not satisfied with the soft tissue positioned in the cradleportion 794, the physician may readily pull back the cartridge 791 byactuating the actuator portion 778 proximally, view and re-arrange thesoft tissue in the cradle portion 794, and then actuate the actuatorportion 778 distally to move the cartridge 791 against the soft tissue,as previously set forth. Once the physician is satisfied with thepositioning of the soft tissue with the cartridge 791 actuated againstthe soft tissue, the physician may activate the firing member 776. Thefiring member 776 may then be activated to force one or more anchorsfrom the cartridge 791 and through the soft tissue such that legs of theone or more anchors may wrap around portions of one or more platespositioned under the soft tissue. In this manner, the delivery device770 may be employed to fixate any one of the repair device embodimentsdescribed herein to soft tissue.

The various repair device embodiments or other embodiments disclosedherein may be applied to any one of various soft tissue to soft tissuerepairs as well as soft tissue to bone repairs. For example, the variousrepair device embodiments may be employed for flexor tendon repairs,patellar tendon repairs, Achilles tendon repairs, quadriceps tendonrepairs, and/or bicep tendon repairs, or any other tendon, ligament, andtendon/ligament to bone repairs. As such, the repair device may beappropriately sized for proper fixation to the different sized or typesof soft tissue.

While the invention may be susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and have been described in detail herein.However, it should be understood that the invention is not intended tobe limited to the particular forms disclosed. Rather, the inventionincludes employing any portion of one embodiment with anotherembodiment, all modifications, equivalents, and alternatives, fallingwithin the spirit and scope of the invention as defined by the followingappended claims.

What is claimed is:
 1. A delivery device system for fixating a repairdevice to soft tissue at a soft tissue repair site, comprising: adeployment mechanism having a handle associated with a trigger, thehandle and trigger sized and configured to manually deploy the repairdevice into soft tissue with a push rod moveable along an axis, the pushrod linearly moveable by the deployment mechanism and extending distallyfrom the deployment mechanism; a housing extending longitudinally alongthe push rod; an anvil and cartridge configured to be coupled to thehousing, the cartridge at least partially holding the repair device; aworm drive positioned within the housing; a thumb wheel disposed aroundthe worm drive, the thumb wheel configured to be rotated to linearlymove the worm drive with threads defined in at least one of the wormdrive and the thumb wheel such that the worm drive is configured tolinearly move the cartridge relative to a bed surface of the anvil; anda finger element extending from the worm drive and configured tocooperate with an internal surface of the thumb wheel such that, uponrotating the thumb wheel, the worm drive rotates with the finger elementengaged with the internal surface of the thumb wheel.
 2. The deliverydevice system of claim 1, wherein the internal surface of the thumbwheel defines multiple slots therein, the finger element sized tolinearly translate along one slot of the slots as the worm driverotates.
 3. The delivery device system of claim 2, wherein, upon thecartridge being linearly moved against soft tissue positioned in theanvil, the finger element is configured to slip-out of the one slot toprevent further linear movement of the cartridge toward the bed surfaceof the anvil.
 4. The delivery device system of claim 1, wherein thefinger element comprises a circular member.
 5. The delivery devicesystem of claim 1, wherein the finger element comprises a ringstructure.
 6. The delivery device system of claim 1, further comprisinga stroke regulator positioned between the deployment mechanism and theworm drive.
 7. The delivery device system of claim 6, wherein the strokeregulator comprises an elastomer material.
 8. A delivery device systemconfigured to move a cartridge with a repair device disposed thereintoward an anvil with soft tissue positioned thereon for fixating therepair device to the soft tissue at a soft tissue repair site, thedelivery device system comprising: a housing; a worm drive positionedwithin the housing; a thumb wheel disposed around the worm drive, thethumb wheel configured to be rotated to linearly move the worm drivewith threads defined in at least one of the worm drive and the thumbwheel such that the worm drive is configured to linearly move thecartridge relative to a bed surface of the anvil; and a finger elementextending from the worm drive and configured to cooperate with aninternal surface of the thumb wheel such that, upon rotating the thumbwheel, the worm drive rotates with the finger element engaged with theinternal surface of the thumb wheel.
 9. The delivery device system ofclaim 8, wherein the finger element comprises a circular member.
 10. Thedelivery device system of claim 8, wherein the finger element cooperateswith the internal surface of the thumb wheel by linearly translatingalong a length of the internal surface of the thumb wheel such that thefinger element limits a force of the cartridge being pushed against thesoft tissue by the finger element slipping over a slot defined in theinternal surface of the thumb wheel.